3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
Phase: NA
Conditions: Enlarged Prostate
Sponsor: University of Miami

Version #B, Date: February 20, 2018 
 
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TITLE: 
 
 3D ROTATIONAL CT ANGIOGRAM WITH EMBOLIZATION 
GUIDANCE AND CBCT IN PROSTATE ARTERY 
EMBOLIZATION 
 
 
 
   
 
 
Sponsor: 
 
  SHIVANK BHATIA MD  
 
 
 
  University of Miami 
 
 
 
  Interventional Radiology  
 
 
 
  Dominion Towers 
 
 
 
  1400 NW 10th Avenue, Suite 1114 
 
 
 
  Miami, FL 33136 
 
 
 
  National Clinical Trial Identifier:   
NCT03164629 
 
  VERSION:   
 
 
 
B 
 
  Date of Protocol:                 
 
February 20, 2018 
 
 
 
   
 
  
 
 

Version #B, Date: February 20, 2018 
 
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1) Protocol Title 
3D Rotational CT angiogram with Embolization guidance and CBCT in Prostatic 
Artery Embolization 
2)   Primary Objective 
To ascertain the feasibility of cone-beam CT with Embolization Guidance software 
(Emboguide) to identify prostatic arteries and assist  endovascular navigation, by projecting a 
3D road map of prostatic arteries on live fluoroscopy, in order to  differentiate them from 
non-target vessels. The primary outcome measurement will be the time for prostatic 
artery catheterization.  
o For the cases using Emboguide this will be measured as the time from which 
the Emboguide is displayed on the live fluoroscopy to the time of prostatic 
artery catheterization. Emboguide display is in addition to the angiogram 
roadmap display. 
o For the control cases this will be measured as the time from which the 
angiogram is displayed on the live fluoroscopy to the time of prostatic artery 
catheterization. 
 
3) Background 
 
Direct clinical translation – University of Miami has been performing Prostatic Artery 
Embolization (PAE) since 2014 and has significant experience with the procedure. 
Technical challenges are encountered on a routine basis. The combination of 3D rotational 
CT, Emboguide and cone beam CT has tremendous potential to standardize and optimize a 
software protocol to aid in identification, catheterization, and embolization during the 
technically challenging PAE procedure. The data from this feasibility study might be used 
for a subsequent grant proposal (individually or in conjunction with other proposals) to 
improve the safety and efficacy of PAE. 
 
The proposed study is a proof of concept investigation to assess a new clinical application. 
Current technical challenges to the widespread adoption of PAE include  identification and 
catheterization of arteries appropriate for embolization. Prostate arteries are frequently 
tortuous, with duplication or replacement and varying sites of origin, and due to the nature 
of the patient population, atherosclerosis further complicates identification and navigation. 
An imaging system that could assist with identification and catheterization has the potential 
to improve patient outcomes by facilitating more complete embolization, avoidance of non-
target vessel occlusions, and reduction of radiation exposure time. 
With the current proposal, the software application can be standardized and tailored to 
optimize safety and efficacy of prostate embolization, which has been shown in clinical 
trials to be an effective alternative treatment of enlarged prostate or bladder outlet 
obstruction.  
 
Another advantage of the protocol is it may obviate the need for pre-procedure CT 
angiogram, further reducing radiation exposure and procedure time. 

Version #B, Date: February 20, 2018 
 
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4) Inclusion and Exclusion Criteria* 
 
Inclusion criteria: 
 
1) Patient is age 50 to 79, inclusive 
2) Patients undergoing Prostate artery embolization for BPH or urinary retention 
3) Patient has signed informed consent (able to consent).  
 
Exclusion criteria: 
  
1) Patients with biopsy proven prostate cancer  
2) Patient weight of >300 lbs. 
 
 
5) 
Local Number of Subjects* 
         Approximately 50 patients will be enrolled at this investigator site no screening failures are 
anticipated since all 50 patients will receive PAE and cone-beam CT. Currently cone-beam 
CT is performed routinely for all PAE cases. 25 sequential patients will undergo PAE with 
3D angiogram and Emboguide. This will be followed by 25 sequential patients who will 
undergo PAE with no 3D angiogram nor Emboguide. 
 
6) 
Study Timelines* 
The study duration will be approximately one year from the start date. The enrollment will 
take about 8 months and data analysis will take about 3 months. 
 
 
7) 
Study Design/Procedures Involved 
This is a single center prospective study. The patients eligible for the PAE for benign prostate 
hyperplasia will be offered the study and inform consent will be obtained. Once patient has 
been referred to Interventional Radiology (IR) and prior to the clinic visit with the IR 
physician, the records of the patient will be accessed for screening purposes. Patients will be 
recruited for participation in the study during routine consultation for the prostate 
embolization procedure. The main challenge of the PAE procedure remains the identification 
of the prostatic arteries and their super-selective catheterization. Contrast enhanced cone-
beam CT (Dyna-CT) is already performed at our center as part of the PAE clinical protocol 
to reduce the risk of non-target embolization, especially to the rectal, bladder and penile 
vasculature. We will initially obtain a 3D rotational selective angiography of the internal iliac 
artery for study group. This dataset will be called the PLANNING dataset. We will assess if 
superimposing the pre-catheterization 3D dataset (in which the physician marks the prostate 
and its arterial feeders), can be used as an Emboguide tool along with overlay from a 
conventional DSA. This will be transmitted to live fluoroscopy and be used as an aid to 
catheterization of the prostatic arteries in the study group.  

Version #B, Date: February 20, 2018 
 
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Study Group 
 
The following parameters will be recorded for the study group:  
 
• 
Time for catheterization as defined above  
• 
Time for planning dataset for each side 
• 
Total dose area product 
• 
Dose for planning dataset for each side  
• 
Dose area product only for fluoroscopy 
• 
Total procedural time: from access to closure 
• 
Amount of contrast medium used   
 
Control Group 
 
The following parameters will be recorded for the control group: 
 
• 
Time for catheterization as defined above 
• 
Total dose area product 
• 
Dose area product only for fluoroscopy 
• 
Total procedural time: from access to closure. 
• 
Amount of contrast medium used   
 
The tortuosity of the vessels will be graded in each case and will be categorized into: 
1- Mild  
2- Moderate 
3- Severe 
 
This will be graded visually for every case and will be noted on the case report forms. 
We will also study the arterial supply to the prostate gland with any anatomic variants 
including duplicated prostatic arteries or prostate arteries arising from less common 
branches such as common gluteal-pudendal trunk, obturator artery, and inferior gluteal 
artery in all patients. 
 
8) 
Data Storage  
All data collected will be stored in a password protected database in a password protected 
computer of Interventional Radiology to which only the PI and study coordinator or other 
key research personnel have access. 
Address: Dominion Towers  
  
1400 NW 10th Avenue, Suite 1114 
                Miami, Florida 33136 
 
9) 
Data Management* 
The statistical analysis for the current study will be conducted as follows. The following 
variables and parameters will be collected: 
o Time for catheterization 

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o Time for planning dataset for each side (This will be evaluated as the time 
from completion of the 3D angiogram to beginning of catheterization) 
o Total dose area product,  
o Dose for planning dataset for each side,  
o Dose area product for fluoroscopy only,  
o Total procedure time, and  
o The amount of contrast media used.   
Descriptive statistics (mean, median, range, and standard deviation) will be computed for 
the treatment group and the control group and values will be compared for the variables of 
interest.  
Additionally, a statistical significance comparison between the study group (with guidance) 
and the control group (without guidance) will be computed for several parameters. 
Specifically, the differences in means and/or medians between the following variables and 
parameters will be analyzed using a T-test or a Mann-Whitney test (depending on 
normality of the distribution and other assumptions): 
o Time for prostate artery catheterization for each group 
o Total dose area product (this will include DAP from the planning dataset in 
the study group) 
o  Dose area product only for fluoroscopy,  
o Total procedure time, and  
o The amount of contrast medium used.     
 
10) Withdraw of Subject 
Patients can withdraw from the study at any time, without penalty or benefit. This study 
may be discontinued, without the patients consent, at any time by the study doctor, if he/she 
believes that participation in the study is no longer in their best interest. 
 
11) Risks to Subjects* 
Subjects will have one or more medical imaging studies (x-ray like films) which use 
radiation (emission or transmission of energy in the form of waves or particles). The tests or 
treatments include a whole body CT scan. To give an idea about how much radiation the 
patients will get, we will make a comparison with an every-day situation. Everyone 
receives a small amount of radiation that cannot be avoided each year. Some of this 
radiation comes from space and some from naturally-occurring radioactive forms of water 
and minerals. This research gives your body the equivalent of about 3 extra years' worth of 
this natural radiation. Subjects will be exposed to radiation as per their standard of care 
treatment. The investigational group will be subject to additional radiation for the 3D 

Version #B, Date: February 20, 2018 
 
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planning dataset, however this in turn might reduce the duration of prostate artery 
catheterization leading to similar or reduced radiation if the 3D dataset was not used.  
 
12) 
Potential Benefits to Subjects* 
There are no current direct benefits for patients, however there may be advantages to future 
patients if it is determined that this technology can obviate the need for pre-procedure CT 
angiogram and increase the safety of the procedure by reducing the risk of non-target 
embolization. 
 
13) 
Sharing of Results with Subjects* 
The results will not be shared with subjects as there is no direct advantage to the patient 
and they are not related to clinical outcomes of the procedure. 
 
14) 
Setting 
Patients will be identify and recruited at PAC Radiology Clinic. The study procedures will 
be performed at UMHC. 
 
15) 
Recruitment  
Patients who require PAE will be referred by their Urologist or will visit an Interventional 
radiologist. This is a single center study. The patients eligible for the PAE for BPH will be 
offered the study and informed consent will be obtained. Patients will be recruited for 
participation in the study during routine consultation for the prostate embolization 
procedure. 
 
16) 
Confidentiality 
Subject study files will be stored in a double locked cabinet to which only the investigators 
and research team have access. The address is 1400 NW 10th Avenue Suite 1114, Miami, 
Florida 33136. The only member(s) of the study team with access to it will be Lia Quezada. 
The data will be stored for up to 2-3 years after the study is completed and will be 
destroyed in accordance with university policies thereafter. 
 
 

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17) 
Provisions to Protect the Privacy Interests of Subjects 
The Investigators and research team will ensure that the subject understands that only their 
information from the procedure will be collected. No other follow up visits will occur. All 
study records will identify patients by study identification number.  
 
18)  Compensation for Research-Related Injury 
Subjects will not be compensated. 
 
19) 
Economic Burden to Subjects 
Subjects will bear the cost that they will normally pay for their standard of care procedure 
but no additional costs associated with participation in the study.  
 
20) 
Consent Process 
Written Informed consent and HIPAA forms will be obtained to collect the data from those 
prospective subjects who agree to participate. Three copies will be obtained, the original 
will be kept in the subject’s file with the research team, the second will be provided to the 
patient and last will be placed in the medical record so it can be scanned to UChart. 
A partial waiver of HIPAA for screening purposes is being requested. Once patient 
has been referred to Interventional Radiology (IR) and prior to the clinic visit with 
the IR physician, the records of the patient will be accessed for screening purposes. 
Non-English Speaking Subjects: The ICF will be translated into Spanish once we 
have received approval from the IRB. 
21) 
Process to Document Consent in Writing 
The research team will document the informed consent process for every participant who 
will prospectively participate in the study. Patients will be consented at PAC Clinic. 
Address: Professional Art Center 
 
 
  1150 NW 14th Street 
 
 
  Miami, Florida 33136  
 
22) 
Drugs or Devices 
The device is the cone-beam CT 3D Embolization guidance software which is currently 
being used at UMHC for Interventional radiology clinical purpose only. 
 
23) 
Resources Available 
The Interventional Radiology Department has 14 IR attending physicians well 
trained in the fields of Interventional Radiology and Interventional Oncology. It 
also has a dedicated research team: 
   Lia Quezada, BA:  Clinical Research Coordinator has been in research since 2007