Diagnostic Ultrasound for Measuring Fat of the Body
Phase: NA
Conditions: Subcutaneous Fat
Sponsor: Northwestern University

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PROTOCOL TITLE:  Diagnostic ultrasound for measuring fat of the body
PRINCIPAL INVESTIGATOR:
Murad Alam, MD
Professor of Dermatology, Otolaryngology, and Surgery
Northwestern University
Department of Dermatology
Feinberg School of Medicine
676 N Saint Clair Street, Suite 1600
Chicago, IL 60611
312-695-4761
m-alam@northwestern.edu
VERSION NUMBER:
1.1
PROTOCOL #:
MA07272018
VERSION DATE:
9-28-18
STUDY SUMMARY:
Investigational Agent(s) 
(Drugs or Devices)
LOGIQ P6 Diagnostic Ultrasound (GE Healthcare, 
Wauwatosa, WI)
IND / IDE / HDE # Exempt/ no risk/ FDA cleared
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
40
Funding Source
Investigator-initiated/ Department of Dermatology
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site ( For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
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OBJECTIVES:
To provide information about human subcutaneous fat thickness at different anatomic sites on 
the body by (1) measuring these thicknesses with a diagnostic ultrasound and also by (2) 
correlating patient perceptions of body image with measured fat distribution.  The information 
obtained can useful in clarifying: (1) age, gender, and racial differences in subcutaneous fat 
accumulation that may inform patient education and (2) help us better understand which 
procedures may be better for particular patients.
BACKGROUND: (flesh out and refs)
High-frequency ultrasound allows for non-invasive assessment of physiological and pathological 
aspects of the integumentary system.1 Although classical ultrasound (7.5-10 MHz) is not 
commonly used in dermatology, ultrasonography with frequencies of at least 20 MHz can 
provide information on tumoral extension, inflammatory infiltrate, and collagen content in various 
anatomical regions, with different intervals of age.2,3 High-frequency ultrasound serves as an 
alternative to skin biopsy, the gold standard for investigation. 4,5 The use of high-frequency 
ultrasound also allows for a clear identification of skin layers and tissue assessment, allowing 
for the establishment of an imagistic aging model.5,6,7 Microstructures have been characterized 
when ultrasound frequencies above 10 MHz have been used.5 Additionally, high-frequency 
ultrasound helps identify variations in both skin thickness and echogenicity. Specifically, dermal 
density and echogenicity throughout the senescence process can be identified.5
To our knowledge, there have been no studies investigating relevant anatomy of the body using 
ultrasound technology for fat measurement and how this corresponds to patient perceptions of 
their body. This study seeks to remedy this deficiency. 
STUDY ENDPOINTS:
The primary endpoints are the descriptive differences seen fat measurements taken with a 
diagnostic ultrasound, and the correlating the measurements with patient perceptions of body 
image with a questionnaire.
STUDY INTERVENTION(S)  / INVESTIGATIONAL AGENT(S):
Drug/Device Handling: LOGIQ P6 Diagnostic Ultrasound (GE Healthcare, Wauwatosa, WI). 
Only trained and authorized personnel will operate the ultrasound.  The microscope will be 
stored in a locked space in the Department of Dermatology at 676 N. St. Claire, Suite 1600, 
Chicago, IL 60611.
The ultrasound gel is the standard of care gel used when obtaining ultrasound images: 
AQUASONIC® 100 ULTRASOUND TRANSMISSION GEL (Parker Laboratories, Inc., Fairfield, NJ).
This gel and device is being used per the FDA approved use for imaging and there is no 
investigational use. This device is a non-significant risk device. 
PROCEDURES INVOLVED:
Screening Visit (Day 0)
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-
Inclusion/exclusion criteria reviewed
-
Written consent signed
-
After the subject has provided signed and informed consent, he/she will be assigned a 
unique subject identification number. 
Imaging Visit (Day 0)
-
Participant demographics will be collected, including height and weight (Appendix II)
-
Macroscopic photography will be obtained of the participant with a DSLR camera using 
ambient lighting and standardized positioning (front, 90 degrees, and back)
-
Ultrasound gel will be applied to the ultrasound probe to be in contact with the skin areas.
-
Ultrasound images will be obtained from various regions of the body, but not limited to:
o
Submental area
o
Upper inner arms
o
Upper back
o
Flanks
o
Abdomen
o
Inner thighs
o
Outer thighs
-
Participants will fill out a questionnaire (Appendix I) about their perceptions of their body.
SHARING RESULTS WITH PARTICIPANTS
The Principal Investigator or sub-investigators may publish the results of this study in 
conjunction with appropriate scientific and medical personnel. The study results will not be 
shared directly with study participants, however, subjects interested in the study findings will be 
able to find them upon publication in a peer-reviewed journal.
STUDY TIMELINES
-
The duration of each subject’s participation in the study is 3 hours. 
-
Enrollment of all study participants is expected to take up to 7 months
-
The estimated date for completion of the study’s primary analysis is March 2019.
INCLUSION AND EXCLUSION CRITERIA
Inclusion criteria
1.
Males or females 18-85 years old.
2.
Subjects are in good health as judged by the investigator.
3.
Subjects with Body Mass Index (BMI) between 18-29.99.  
4.
Subjects who are willing and have the ability to understand and provide informed 
consent for participation in the study and are able to communicate with the investigator
Exclusion criteria
1.
Evidence of another skin condition affecting the treatment area that would interfere with 
clinical assessments
2.
Pregnant or breast feeding
3.
Uncooperative patients or patients with neurological disorders who are incapable of 
following directions 
4.
Subjects who are unable to understand the protocol or give informed consent (including 
non-English speaking patients).
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PARTICIPANT POPULATION(S)
Accrual 
Number:
Category/Group:
(Adults/Children 
Special/Vulnerable 
Populations)
Consented:
Maximum Number to be 
Consented or 
Reviewed/Collected/Screened
Enrolled:
Number to Complete 
the Study or Needed 
to Address the 
Research Question
Local
Adults
50
40
Study-wide
Adults
50
40
Total:
Adults
50
40
RECRUITMENT METHODS

The investigator will passively inform subjects presenting to the Department of 
Dermatology Clinic at Northwestern University who meet the inclusion criteria. Those 
expressing an interest in study participation will be contacted by study personnel for a 
verbal explanation and discussion of the protocol.

Printed and electronic advertisements will be posted on the Northwestern University 
Medical Campus and on the internet. Interested potential participants will contact study 
personnel for a verbal explanation and discussion of the protocol.
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
 Participants will receive a $25 Visa debit card at the completion of the study.
WITHDRAWAL OF PARTICIPANTS
Criteria for terminating study participation
-
Subject wishes to stop being in the study
-
Subject no longer qualifies based on inclusion/exclusion criteria
-
Adverse events occur that, in the opinion of the investigator, put the subject at increased 
risk and it is not in the best interest of the subject to continue the study
RISKS TO PARTICIPANTS
Photographs:
There is a possibility that subjects will be able to be identified from the photographs that 
will be taken for the study. 
Ultrasound:
There is a possibility that subjects will be able to be identified from the ultrasound 
images that will be taken for the study. 
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Allowing the machine to transmit acoustic output with the probe not in use (or in its 
holder) can cause the transducer to build up heat.  The probe therefore may be warm on 
the skin.
The use of damaged probes can result in injury or increased risk of infection. A damaged 
probe can also increase the risk of electric shock if conductive solutions come in contact 
with internal live parts. 
Ultrasound can produce harmful effects in tissue and potentially result in patient injury. 
Exposure time will be minimized per area and ultrasound levels will be kept low when 
there is no medical benefit.
Ultrasound Gel: 
There is a possibility that the ultrasound gel can cause skin irritation or skin allergic 
reactions.
POTENTIAL BENEFITS TO PARTICIPANTS
There is no direct benefit to the participant. The knowledge gained from this study could provide 
valuable information about anatomical fat measurements and how this corresponds to patient 
perceptions of their body..
DATA MANAGEMENT AND CONFIDENTIALITY
Statistical Analysis
Deidentified study data will be into a Microsoft Excel spreadsheet by authorized members of the 
research team. This is a descriptive study and no statistics will be performed other than any 
descriptive statistics. Power study and sample size were not performed since this is a 
descriptive study with descriptive analysis.
Data Storage
The study team will enter subject data into a spreadsheet and/or eCRFs that will be accessible 
to IRB authorized site personnel through a secure internet connection immediately after entry.  
Subject data will be de-identified; each subject will be given a unique identifier code and an 
additional spreadsheet with the unique identifier codes will be maintained on password 
protected computers, in password protected network folders. Data, photos, and ultrasound 
images will be stored in a secure drive (FSM Research Files drive) which is maintained by 
Northwestern University.  Paper source documents will be kept in the department office in a 
locked file cabinet.  Access to locked cabinets will be granted only to the PI and authorized 
study personnel.  After study completion; all study documentation, including regulatory 
documents, copies of eCRFs, signed informed consent forms will be kept on-site in a secure 
locked cabinet for at least one month.  Study documents may be shipped after one month to 
Iron Mountain, an off-site record storage/management facility.  All study records are indefinitely 
stored per Iron Mountain’s policies and procedure.  Data generated as a result of this study are 
to be available for inspection on request by the Northwestern University Institutional Review 
Board (IRB).
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS
Participants have the right to be treated with respect, including respect for their decision 
whether or not they wish to continue or stop being in the study. They are free to choose to stop 
being in the study at any time.
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Choosing not to be in the study or to stop being in this study will not result in any penalty to 
them or loss of benefit to which they are entitled. Specifically, their choice not to be in this study 
will not negatively affect their right to any present or future medical treatment or present or 
future employment to which they are otherwise entitled.
ECONOMIC BURDEN TO PARTICIPANTS
Subjects will be responsible for transportation costs, although they will be offered parking 
validation to partially cover parking expenses at the treatment site. 
CONSENT PROCESS
Prior to performing any research procedures, consent for participation will be obtained in writing 
by signature on a consent form by the study staff at the in a quiet room (e.g. the exam room) at 
the study site. The consent form will be read by the subject and the subject will be encouraged 
to take all the time they need and to ask any clarifying questions they may have. Approximately 
30 minutes will be devoted to the consent discussion. A copy of the subject’s signed consent 
form will be retained in the study file. 
Only authorized personnel that have been listed in the application as being involved in consent 
will have a role in consent.  
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
We are committed to respect participant privacy and to keep their personal information 
confidential. Personal health information from their medical records and information that can 
identify them may be used. For example, personal health information may include name, 
address, phone number or e-mail address.
The health information we may collect and use for this research may include the following:

all information in a medical record,

results of physical examinations,

medical history,

lab tests, or certain health information indicating or relating to a particular condition as 
well as diaries and questionnaires,

records about study medication or drugs,

records about study devices.
During this study, the participant may be coming to the Northwestern Memorial Healthcare 
Corporation (NMHC) clinical offices for research appointments or to get clinical services, such 
as lab tests, needed for the study. When that happens, they will be scheduled for these services 
through the NMHC computer system. When a clinical exam or lab is done by NMHC or one of 
its employees for the purpose of this research study, that information will be kept in both 
NMHC's clinical records and in the study records.
Subject medical information obtained during this study is considered confidential and disclosure 
to their parties other than the principal investigator and the co-investigators is prohibited. All 
reports and communications relating to subjects in this study will identify each subject only by 
their initials and subject identification number. Medical information resulting from a subject’s 
participation in this study may be given to the subject’s personal physician or to the appropriate 
medical personnel responsible for the subject’s welfare. Data generated as a result of this study 
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are to be available for inspection upon the Northwestern University Institutional Review Board 
(IRB).
NON-ENGLISH SPEAKING PARTICIPANTS
Only English-speaking patients will be enrolled in the study as inability to understand the 
protocol or give infomed consent (e.g., due to lack of English-speaking abilities) would fail to 
meet eligibility criteria (see Exclusion Criteria).
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
All research related study visits will take place in the Department of Dermatology from 
presenting participant populations.  
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REFERENCES:
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2. Diridollou S, Berson M, Vabre V et al. An In Vivo Method for Measuring the Mechanical 
Properties of the Skin Using Ultrasound. Ultrasound Med Biol. 1998;24(2):215-224. 
doi:10.1016/s0301-5629(97)00237-8.
3. Wolz M, Goss B, Baum C, Arpey C. Ultrasound and Fine-Needle Aspiration in Dermatology, 
Underuse of Minimally Invasive, Efficient Diagnostic Tools. Dermatologic Surgery. 
2014;40(3):275-280. doi:10.1111/dsu.12430.
4. Sogabe M, Okahisa T, Hibino S, Yamanoi A. Usefulness of differentiating metabolic 
syndrome into visceral fat type and subcutaneous fat type using ultrasonography in 
Japanese males. J Gastroenterol. 2011;47(3):293-299. doi:10.1007/s00535-011-0489-4.
5. Crisan D, Lupsor M, Boca A, Crisan M, Badea R. h. Indian J Dermatol Venereol Leprol 
2012;78:519
6. Yoshimatsu T, Yoshida D, Shimada H, Komatsu T, Harada A, Suzuki T. Relationship 
between near-infrared spectroscopy, and subcutaneous fat and muscle thickness 
measured by ultrasonography in Japanese community-dwelling elderly. Geriatr Gerontol 
Int. 2012;13(2):351-357. doi:10.1111/j.1447-0594.2012.00906.x.
7. Lo Presti D, Ingegnosi C, Strauss K. Skin and subcutaneous thickness at injecting sites in 
children with diabetes: ultrasound findings and recommendations for giving 
injection. Pediatr Diabetes. 2012;13(7):525-533. doi:10.1111/j.1399-5448.2012.00865.x.
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