Clinical trial NCT02669784
Conditions: Aortic Aneurysm Contrast Induced Nephropathy Aortic and Arterial Anomalies
Sponsor: Milton S. Hershey Medical Center
Start date: 2016-02-01; Completion date: 2018-11-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.

Detailed description:
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below.

CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.

CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds.

Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.

Arms: arm 1: CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. arm 2: CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date.
Interventions: intervention 1: Low Dose Contrast (Omnipaque) 40mL intervention 2: Low Dose Contrast (Omnipaque) 50 mL
Intervention descriptions: intervention 1: The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec. intervention 2: The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.

Protocol documents:
Prot_SAP_000.pdf: 
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HRP-591 - Protocol for 
Human Subject Research 
Protocol Title:
Does reduction in contrast administration dose in computed tomography arteriograms degrade image quality? A single 
institutional review of an ultra-low contrast dose protocol.
Principal Investigator:
Name: Dr. Rekha Cherian
Department: Radiology
Telephone: 717-531-8044
E-mail Address: rcherian@pennstatehealth.psu.edu
Version Date:  19 July 2017
Clinicaltrials.gov Registration NCT02669784
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Confidentiality, Privacy and Data Management
10.0
Data and Safety Monitoring Plan
11.0
Risks
12.0
Potential Benefits to Subjects and Others
13.0
Sharing Results with Subjects
14.0
Subject Stipend (Compensation) and/or Travel Reimbursements
15.0
Economic Burden to Subjects
16.0
Resources Available
17.0
Other Approvals
18.0
Multi-Site Research
19.0
Adverse Event Reporting
20.0
Study Monitoring, Auditing and Inspecting
21.0
Future Undetermined Research: Data and Specimen Banking
22.0
References
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1.0
Objectives
1.1
Study Objectives
The purpose of the study is to determine if the dose of contrast administered for computed 
tomographic arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is 
that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to 
routine dose exams. 
1.2
Primary Study Endpoints
The objective is to prospectively evaluate image quality of CTA examinations performed with an ultra-
low contrast dose protocol. The primary endpoint would be to show that there is no statistical 
difference in the quality of the images.
1.3
Secondary Study Endpoints
Not Applicable
2.0
Background 
2.1
Scientific Background and Gaps
Currently, at our institution, routine CTA examinations are obtained with a dose of 100mL of 
intravenous contrast. In the setting of renal dysfunction, this dose is reduced to 75mL to minimize the 
risk of contrast induced nephropathy. This dose can be further adjusted giving some flexibility 
depending on the BMI of the patient and type of scanner used. Given the recent advancements of 
computed tomography hardware, the scanning speed has greatly increased allowing for reduction in 
contrast dose. However, at our institution, the dosage and administration rate of intravenous 
contrast has not yet been adjusted to take advantage of improvements in scanning hardware.
2.2
Previous Data
A small number of patients have been imaged with a decreased contrast dose (up to 60% less contrast 
volume). By taking advantage of scanner speed and number of detectors, a smaller overall dose can be 
given while still obtaining adequate diagnostic imaging. Quantitative measurements of vascular 
enhancement (in Hounsfield units) at select locations show no differences in vascular opacification. In 
addition, qualitative evaluation of these images by board certified diagnostic radiologists show no 
difference in image quality between examinations performed with reduced contrast dose versus 
examinations performed with standard contrast dose. This data suggests that the same quality of 
images can be obtained with a lower dose of contrast minimizing the risk of contrast induced 
nephropathy. No references are available at this time regarding the rate of re-imaging due to non-
interpretable CTA studies. In correspondence with several CT technologists, they stated that in their 
experience, rarely does a CTA of the chest or chest, abdomen and pelvis have to be repeated
2.3
Study Rationale
CTA is the imaging of choice for the evaluation of the aorta. Aortic CTAs are performed for evaluation of 
acute aortic syndromes, vasculitidies, as well as chronic conditions such as aortic aneurysms and 
congenital anomalies. Examinations are performed for pre-operative evaluation and post-operative 
follow up in many of these patients. This patient population includes patients with many comorbidities, 
such as hypertension and diabetes, as well as elderly patients. All these conditions contribute to renal 
dysfunction. For this reason, the radiology department at this institution has a policy to evaluate renal 
function before a contrast enhanced CT scan in the setting of increased age (>60 years), history of renal 
dysfunction or diabetes. Decreasing the contrast dose is important to prevent further damage to the 
kidneys by contrast induced nephropathy (CIN). It is thought that reducing the contrast dose will reduce 
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the risk of nephropathy. Development of a low dose protocol would potentially decrease the risk of 
contrast induced nephropathy in this patient population.  
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
1.
Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or CTA of 
the abdomen or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the 
chest, abdomen and pelvis who had undergone a prior CTA of the same region performed with the 
standard contrast dose (100 mL) at this institution will be included in the study.
2.
The follow-up scan will be routine standard of care, no emergency imaging patient will be 
approached for this research.
3.2
Exclusion Criteria
1.
Patients with no prior CTA imaging for comparison. 
2.
Any pediatric patient (age <18). 
3.
BMI >40
4.
Inability to follow instructions.
5.
Allergy to intravenous contrast.
6.
GFR less than 60 mL/min/1.73 m2 – GFR should be within normal range. This would allow a repeat study if 
needed and not pose an increased risk to renal dysfunction.
7.
Cognitively Impaired Adults
8.
non-English speaking patients
9.
Pregnant Females
10. Endoleak studies – decreased contrast makes evaluation of an endoleak difficult on delayed imaging.
3.3
Early Withdrawal of Subjects
3.3.1 Criteria for removal from study
Patient may decline or withdraw from participation at any time after the consent is signed.
3.3.2
Follow-up for withdrawn subjects
The information required for the study is obtained at the initial time of evaluation. If a person 
declines to participate, no data will be acquired. There is no reason to follow up withdrawn 
subjects.
4.0
Recruitment Methods
4.1
Identification of subjects
Medical records of adult patients scheduled for a routine computed tomography arteriogram will be 
evaluated prior to CTA imaging to identify subjects meeting the inclusion/exclusion criteria.
4.2
Recruitment process
Patients scheduled for routine CTA examinations will be screened, via medical records, to find out if they 
have had a prior CTA of the aorta with routine dose of intravenous contrast within the past two years. 
Those patients within this group that meet inclusion criteria and do not have any exclusion criteria will 
be offered to participate in the study.
4.3
Recruitment materials
Not Applicable
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4.4
Eligibility/screening of subjects
We will be entering medical records to screen for eligibility. Therefore, we are requesting a waiver of 
consent and a HIPAA waiver of authorization to screen for eligibility criteria prior to the consent form 
being signed.
5.0
Consent Process and Documentation 
5.1
Consent Process 
 
5.1.1
Obtaining Informed Consent
5.1.1.1 Timing and Location of Consent
Informed consent will be obtained prior to examination in the IV preparation 
room or scanner room. 
5.1.1.2 Coercion or Undue Influence during Consent
The individual obtaining consent will explain to the patient that participation is 
voluntary; that they do not have to take part in this research and that they can 
withdraw at any time. The decision whether or not to participate will have no 
impact on the availability of their current and future care within PSHMC.  They 
will also be told that there is no compensation or reward for participating in the 
study.
5.1.2
Waiver or alteration of the informed consent requirement
We will be requesting a waiver to enter medical records to screen for eligibility.
5.2
Consent Documentation
5.2.1
Written Documentation of Consent
Informed consent will be documented through the use of the long form consent. The language 
used in the informed consent document will be understandable to the subject. Both the subject 
and the person obtaining consent will sign the document, along with the date informed consent 
was obtained/given. A copy of the signed and dated informed consent document will be given to 
the subject. A signed copy of the consent will also be included in the patient’s medical record.
5.2.2
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.)
Not Applicable
5.3
Consent – Other Considerations 
5.3.1
Non-English Speaking Subjects
Not Applicable
5.3.2
Cognitively Impaired Adults
5.3.2.1 Capability of Providing Consent
Not Applicable
5.3.2.2 Adults Unable To Consent
Not Applicable
5.3.2.3 Assent of Adults Unable to Consent
Not Applicable
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5.3.3
Subjects who are not yet adults (infants, children, teenagers) 
5.3.3.1 Parental Permission
Not Applicable
5.3.3.2 Assent of subjects who are not yet adults
Not Applicable
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1 Plan to protect PHI from improper use or disclosure
Information is included in the “Confidentiality, Privacy and Data Management” 
section of this protocol.
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers 
As the CTA scan is part of the patient’s medical care, the images, with identifiers, 
will remain in the patient’s medical record. The study linking list will be destroyed 
as per study guidelines.
6.2.2
Explanation for why the research could not practicably be conducted without access to and 
use of PHI
Given that subject eligibility is based on previous CTA imaging with standard contrast dose (100 
mL), it would not be possible to identify potential subjects without access to their medical 
records.
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6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Potential subjects’ history of procedures completed at this institution are kept within medical 
records, which contain PHI. Therefore, without a partial waiver, study team members will not be 
able to appropriately identify potential subjects. 
6.3
Waiver or alteration of authorization statements of agreement
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) 
per federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
7.0
Study Design and Procedures
7.1
Study Design
Any adult patient scheduled for routine CTA meeting the inclusion/exclusion criteria and providing 
consent will be included in the study. The patient will be administered a low dose of intravenous 
contrast based on the study examination as described below. The contrast agent being used is 
Omnipaque. The scan will be performed under the supervision of the primary investigator or the 
described team members to make sure that the study is of diagnostic quality.
The following dose protocols will be followed:
CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger 
the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan 
delay will be increased by 2 seconds. 
CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of 
the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest 
(ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical 
mode, the scan delay will be increased by 2 seconds.
All other imaging parameters will remain unchanged, given that the subjects enrolled will be clinical 
patients of the principle investigator.
Following the examination, the primary investigator (PI) or team members will evaluate the images 
obtained with low contrast dose and each patient’s prior CTA examination performed with routine 
contrast dose. This will be done by quantitative and qualitative measures. For the quantitative portion, 
the PI or team members will place regions of interest on predetermined arterial locations to obtain 
measure the degree of opacification. For qualitative measurement, the images will be presented in a 
blind fashion to two thoracic trained board certified radiologists and a board certified interventional 
radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and 
quantitative data for the images obtained with low contrast dose and those for the prior CTA 
examinations performed with routine contrast dose will be compared. This data along with details of the 
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scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and 
BMI at the time of examination) will be recorded in Redcap. 
7.2
Study Procedures
7.2.1
Clinic Visit
The process of obtaining the CTA images will be unchanged from the patient’s standpoint. One 
difference will be that the examination will be supervised by a team member. The intravenous 
contrast dose administered will be decreased according to the parameters written above.  If the 
study is deemed non-diagnostic at the time of scanning, the study will be repeated. The 
standard of care at this institution in the setting of a non-diagnostic study is to repeat the study 
with a 75mL dose of contrast, for a total of 175mL of contrast. Given that the dose of contrast 
that will be administered for this study (40-50mL) is below the routine amount (100mL). 
Performing a repeat study with 75mL of intravenous contrast will not exceed the contrast dose 
that would have been normally administered. 
7.2.2
EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly)
Not Applicable
7.3
Duration of Participation
The individual’s participation will only be for the duration of the CTA examination.
7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1
Description
Intravenous contrast, Omnipaque, will be administered as described above. The intravenous 
contrast is FDA approved for use of CTAs and is a standard of care practice at PSHMC with the 
standard contrast dose of 100 mL. 
7.4.2
Treatment Regimen
At this institution, CTAs are performed with the standard contrast dose of 100 mL. This study 
will administer intravenous contrast, Omnipaque, at a dosage of 40 mL at a rate of 5mL/sec or at 
50 mL at a rate of 5mL/sec as described above.
7.4.3
Method for Assigning Subject to Treatment Groups
Not Applicable
7.4.4
Subject Compliance Monitoring
Not Applicable
7.4.5
Blinding of the Test Article
Not Applicable
7.4.6
Receiving, Storage, Dispensing and Return 
7.4.6.1 Receipt of Test Article 
The intravenous contrast, Omnipaque, will be received according to standard 
practice of the institution
7.4.6.2 Storage
The intravenous contrast, Omnipaque, will be stored according to standard 
practice of the institution.
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7.4.6.3 Preparation and Dispensing
 The intravenous contrast, Omnipaque, will be prepared and administered as 
per standard of care procedures.
7.4.6.4 Return or Destruction of the Test Article
Not Applicable
7.4.6.5  Prior and Concomitant Therapy
Not Applicable
8.0
Subject Numbers and Statistical Plan
8.1
Number of Subjects
The number of study subjects anticipated is 180 patients.
8.2
Sample size determination
This number of patients achieves 80% power, with a 7.5% equivalence margin, at a 5% significance level 
using a two-sided equivalence test of correlated proportions when the actual difference of the proportions 
is zero.
8.3
Statistical methods
Measured data from CTAs performed with low intravenous contrast dose and from CTAs performed with 
routine intravenous contrast dose for each patient will be analyzed using paired t-tests. The statistical 
methodology will be reviewed by consultation with biostatistics. 
9.0
Confidentiality, Privacy and Data Management 
9.1
Confidentiality
9.1.1
Identifiers associated with data and/or specimens
 See the Research Data Plan Review Form
9.1.1.1 Use of Codes, Master List
 See the Research Data Plan Review Form
9.1.2
Storage of Data and/or Specimens
See the Research Data Plan Review Form
9.1.3
Access to Data and/or Specimens
See the Research Data Plan Review Form
9.1.4
Transferring Data and/or Specimens
See the Research Data Plan Review Form
9.2
Subject Privacy
See the Research Data Plan Review Form
10.0 Data and Safety Monitoring Plan
10.1
Periodic evaluation of data
 The PI and research study team will periodically evaluate the data and communicate regarding subject 
safety. Data collected for the first 20 patients will be summarized and submitted to the IRB for review to 
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ensure safety of subjects. This data will include information about image quality of the CTA 
examinations, any adverse events that occurred, and how many subjects required repeat scans. 
10.2
Data that are reviewed
 Data acquired during low-contrast CTA will be reviewed.
10.3
Method of collection of safety information
Data will be collected at time of screening and CTA
10.4
Frequency of data collection
 Data will be collected at time of screening and CTA
10.5
Individuals reviewing the data
 The PI and research study team will be responsible for reviewing data.
10.6
Frequency of review of cumulative data
Cumulative data will be reviewed on a weekly basis by the principal investigator and study team 
members.
10.7
Statistical tests
 Statistical tests are as outlined in section 8.2 and 8.3.
10.8
Suspension of research
Not Applicable
11.0 Risks
There is a minimal risk of loss of confidentiality.
There is a risk of increased radiation if the scan needs to be repeated due to a non-diagnostic clinical exam. If 
the exam is non-diagnostic due to inadequate vascular enhancement, the examination will be repeated. This 
may lead to an increased radiation dose to the patient. It is important to note that non-diagnostic studies can, 
and do occur with the standard volume of contrast currently administered for these examinations. When this 
occurs, the examination is repeated with a second standard or reduced dose of contrast.  Given the low dosage 
of intravenous contrast of the planned low dose protocol, a repeat examination can be performed without 
exceeding the standard of care contrast dose to the patient, 
12.0 Potential Benefits to Subjects and Others
12.1
Potential Benefits to Subjects
There is no guaranteed benefit from participating in this study. Potential benefits to the patient include 
a decrease in contrast dose which inevitably reduces the risk for development of contrast induced 
nephropathy.
12.2
Potential Benefits to Others
Given the increasing number of contrast enhanced studies performed in the hospital each day, the risk 
of contrast induced nephropathy has theoretically increased. Specific populations of patients are 
susceptible to contrast induced nephropathy. Avoidance of this complication by low dose examinations 
can preserve renal function and potentially decrease hospital stay and health care costs.
13.0 Sharing Results with Subjects
Not Applicable
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14.0 Subject Stipend (Compensation) and/or Travel Reimbursements
Not Applicable
15.0 Economic Burden to Subjects
15.1
Costs 
 Subjects will not be responsible for any cost for participating in the study other than their standard of 
care imaging. The repeat CTA scan, contrast and administration, if required, will be provided at no cost 
to patient. 
15.2
Compensation for research-related injury
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of the research-related 
injuries will be charged to subjects or their insurance carriers.
16.0 Resources Available
16.1
Facilities and locations
The research will be conducted in the department of Radiology at Penn State Hershey Medical Center 
500 University Drive Hershey, PA 17033.
16.2
Feasibility of recruiting the required number of subjects
Study investigators regularly see patients for CTA scans. Therefore, the ability to recruit 180 subjects is 
feasible.
16.3
PI Time devoted to conducting the research
The PI has devoted time to academic endeavors.
16.4
Availability of medical or psychological resources
Hershey Medical Center’s Emergency Department is available 24/7.
16.5
Process for informing Study Team
Ultra-low dose protocols will be presented to the Radiation Awareness Group (RAG) committee in the 
Radiology department. Following approval, the CT technologists will be made aware of the protocol 
changes in selected patients meeting inclusion criteria.  In addition, the PI or team members will be 
available to oversee the examination.
17.0 Other Approvals
17.1
Other Approvals from External Entities
Not Applicable
17.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of the Use of Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available on the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/forms
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  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload the 
Radiation Review Form on the “Supporting Documents” page in CATS IRB. This form is available on 
the IRB website at: http://www.pennstatehershey.org/web/irb/home/resources/forms
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The 
scientific review requirement may be fulfilled by one of the following: (1) external peer-review 
process; (2) department/institute scientific review committee; or (3) scientific review by the Clinical 
Research Center Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute 
Scientific Review Committee is required if the study involves cancer prevention studies or cancer 
patients, records and/or tissues. For more information about this requirement see the IRB website 
at: http://www.pennstatehershey.org/web/irb/home/resources/investigator 
18.0 Multi-Site Research
18.1
Communication Plans
Not Applicable
18.2
Data Submission and Security Plan
Not Applicable
18.3
Subject Enrollment
Not Applicable
18.4
Reporting of Adverse Events and New Information
Not Applicable
18.5
Audit and Monitoring Plans
Not Applicable
19.0 Adverse Event Reporting
19.1
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
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(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
20.0 Study Monitoring, Auditing and Inspecting
20.1
Auditing and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.).
21.0 Future Undetermined Research: Data and Specimen Banking
21.1
Data and/or specimens being stored
Not Applicable
21.2
Location of storage
Not Applicable
21.3
Duration of storage
Not Applicable
21.4
Access to data and/or specimens
Not Applicable
21.5
Procedures to release data or specimens
Not Applicable
21.6
Process for returning results
Not Applicable
22.0 References

Seehofnerová A, Kok M, Mihl C, Douwes D, Sailer A, Nijssen E, et al. Feasibility of low contrast media 
volume in CT angiography of the aorta. Eur J Radiol Open 2015;2(0):58–65
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Rubin, Geoffrey D. "MDCT imaging of the aorta and peripheral vessels." European journal of radiology 45 
(2003): S42-S49. Persson PD. Contrast medium induced nephropathy.
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Nephrol Dial Transplant. 2005;20(Suppl 1):ii.Contrast-Induced Nephropathy
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Tadhg G. Gleeson and Sudi Bulugahapitiya American Journal of Roentgenology 2004 183:6, 1673-1689
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Meschi M, Detrenis S, Musini S, et al. Facts and fallacies concerning the prevention of contrast medium 
induced nephropathy. Crit Care Med. 2006;34:2060–2068.
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Contrast-Induced Nephropathy Stewart R. Walsh, MRCSEd; Tjun Tang, MRCS; Michael E. Gaunt, MD, 
FRCS; and Jonathan R. Boyle, MD, FRCSJ ENDOVASC THER 2007;14:92–100
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Gussenhoven MJ, Ravensbergen J, van Bockel JH, et al. Renal dysfunction after angiography; a risk factor 
analysis in patients with peripheral vascular disease. J Cardiovasc Surg. 1991;32: 81–86
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Diehm N, Pena C, Benenati JF, Tsoukas AI, Katzen BT. Adequacy ofan early arterial phase low-volume 
contrast protocol in 64-detector com-puted tomography angiography for aortoiliac aneurysms. J Vasc 
Surg2008;47(3):492–8.
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Low radiation and low-contrast dose pulmonary CT angiography: Comparison of 80 kVp/60 ml and 100 
kVp/80 ml protocolsG. Viteri-Ramírez, A. García-Lallana, I. Simón-Yarza, J. Broncano, M. Ferreira, J.C. 
Pueyo, A. Villanueva,G. Bastarrika , Clinical RadiologyVolume 67, Issue 9, September 2012, Pages 833–
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Pulmonary 64-MDCT Angiography With 30 mL of IV Contrast Material: Vascular Enhancement and Image 
Quality Carol C. Wu, Edward W. Lee, Robert D. Suh, Barton S. Levine, and Bruce M. Barack American 
Journal of Roentgenology 2012 199:6, 1247-1251
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