Autologous Fat GraftingNCT06343831
Quantitative Assessment of Autologous Fat Transfer
A study testing 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), 3-Dimensional (3-D) Photographs (Visit 1- 6) and Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6) in people with Autologous Fat Grafting, run by University of Chicago at 2 sites in United States.
Trial summary
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Fat Grafting
- What is being tested?
- 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), 3-Dimensional (3-D) Photographs (Visit 1- 6) and Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Planned autologous fat transfer or fat grafting reconstruction of the breast or chest wall.
- Able to provide written or electronic informed consent.
- Able to undergo MRI.
Who cannot join
- Vulnerable subjects (children, prisoners, pregnant women).
- Patients who have active cancer, metastatic disease, solid organ transplantation / immunosuppression, or autoimmune diseases.
- Unable to undergo MRI (history of metal contraindication, claustrophobia)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Carlisa Dixon, 773-834-4337, cdixon520@bsd.uchicago.edu
Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu
- Recruiting
The University of Houston
Houston, Texas, 77204
Fatima Merchant, Ph.D, 713-743-8292, fmerchan@central.uh.edu
Fatima Merchant, Ph.D
About this study
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.
Read the detailed description
The purpose of this pilot study is to assess the utility of imaging (photographs, ultrasound (US), and Magnetic resonance imaging (MRI) )to follow outcomes of autologous fat grafting to the chest for reconstruction. The study team will compare images obtained from each of these methods (photographs, ultrasound, and MRI) to visualize changes in the breast over time.
All participants will meet with a member of the research staff at a pre-operative appointment in the Center for Reconstructive Surgery. At Visit 1 participants will be consented, undergo research-specific data collection, surveys, US, MRI scan, 2D photographs, and 3D surface scanning of their torso/breast.
During follow-up Visits 3-6, participants will undergo research-specific 2D photographs and 3D surface scanning of their breast and chest wall. Participants will also have an ultrasound and MRI scan performed during follow-up visits 4-6 in addition to completing a questionnaire to evaluate patient satisfaction and quality of life following fat grafting.
After obtaining a Data Use Agreement (DUA), de-identified photographs and 3D scans of the participants' torsos (area of fat grafting) will be shared with the University of Houston (Dr. Fatima Merchant) to analyze using software developed to look specifically at volume of the breast before and after surgery and compare the 3D photos with the MRI data. No protected health information (PHI) will be shared with the University of Houston or other investigators.
During each clinic visit, relevant data will be extracted from Epic and entered manually into REDCap data forms by a member of the research team.
- Conditions
- Autologous Fat Grafting
- Being tested
- 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), 3-Dimensional (3-D) Photographs (Visit 1- 6), Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6), Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6), BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6)Procedure or surgery
The study participant will be requested to stand upright with hands comfortably behind their back and turn 45 degrees and 90 degrees in either direction for standard anteroposterior (AP), oblique and lateral photos. Standardized photographic poses will be utilized so that only the participant's neck and torso will be visible and all jewelry on the neck and arms will be removed to eliminate potential identifiers. The photographs will be acquired using a commercially available camera or study iPad device.
3-Dimensional (3-D) Photographs (Visit 1- 6)Procedure or surgery
3-Dimensional surface scans of the participant's torso will be acquired using a commercially available handheld camera scanning device that offers texture, geometry, and color acquisition from any complex surface using white light technology, which is safe for exposure to skin and eyes. Prior to imaging, a pattern of lines and dots will be marked on the patient's breasts using a washable marker. The study participant will be requested to sit upright on the exam room table with hands comfortably behind their back while the research staff member moves around their torso with the handheld scanner. The exam room table will then be reclined to a lay-flat position such that the patient is laying supine, and breast imaging will be repeated. Standardized photographic poses will be utilized so that only the participant's neck and torso will be visible and all jewelry on the neck and arms will be removed to eliminate potential identifiers.
Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6)Procedure or surgery
The images will be acquired using a commercially available handheld ultrasound scanning device. The study participant will be requested to sit upright on the exam room table with hands comfortably behind their back while the research staff member obtains images of the specific area of the breast of chest wall to be grafted (V1) and that which was grafted (V4-6). Images usually take 5-10 minutes to acquire depending on the number of areas grafted.
Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6)Procedure or surgery
An MRI of the breast will be obtained around visit 1 and visits 4-6 timepoints. The images will be acquired in collaboration with the Breast Imaging Core and the Magnetic Resonance Research Imaging Center. Dr. Abe (co-investigator, radiology) will review the images to assess volume of the overall breast, the specific areas of the breasts that were grafted.
BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6)Procedure or surgery
The BREAST-QTM measures three satisfaction domains and three quality of life (QoL) domains.6 For BREAST-QTM, each domain has a score range from 0 - 100. A difference in score, either positive or negative, of 10 points is considered clinically "important"; a difference of 20 points is considered clinically "very important." This survey will be administered to participants via iPad during visit 1 and visits 4-6 and takes approximately 10-20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall | Experimental | Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study. Receives: Procedure: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6); Procedure: 3-Dimensional (3-D) Photographs (Visit 1- 6); Procedure: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6); Procedure: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6); Procedure: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
Images will be obtained from photographs, ultrasound, and MRI to compare and follow outcomes of autologous fat grafting to the chest for reconstruction and to visualize changes in the breast over time.
Measured: Visit 1through study completion, an average of 1 year
Secondary outcomes (1)
Change from baseline in quality of life as measured by the BREAST-QTM survey.
The BREAST-QTM is utilized to assess patient- reported cosmetic and reconstructive breast surgery and clinical practice satisfaction and quality of life outcomes.
Measured: Visit 1through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start25 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Fat GraftingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Houston
- Responsible party
- Sponsor
- Investigators
- Summer Hanson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343831
- Sponsor's protocol ID
- IRB23-1646
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Autologous Fat Transfer
- ClinicalTrials.gov ID
- NCT06343831
- Acronym / sponsor ID
- IRB23-1646
- Conditions
- Autologous Fat Grafting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Houston
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.
Detailed description
The purpose of this pilot study is to assess the utility of imaging (photographs, ultrasound (US), and Magnetic resonance imaging (MRI) )to follow outcomes of autologous fat grafting to the chest for reconstruction. The study team will compare images obtained from each of these methods (photographs, ultrasound, and MRI) to visualize changes in the breast over time.
All participants will meet with a member of the research staff at a pre-operative appointment in the Center for Reconstructive Surgery. At Visit 1 participants will be consented, undergo research-specific data collection, surveys, US, MRI scan, 2D photographs, and 3D surface scanning of their torso/breast.
During follow-up Visits 3-6, participants will undergo research-specific 2D photographs and 3D surface scanning of their breast and chest wall. Participants will also have an ultrasound and MRI scan performed during follow-up visits 4-6 in addition to completing a questionnaire to evaluate patient satisfaction and quality of life following fat grafting.
After obtaining a Data Use Agreement (DUA), de-identified photographs and 3D scans of the participants' torsos (area of fat grafting) will be shared with the University of Houston (Dr. Fatima Merchant) to analyze using software developed to look specifically at volume of the breast before and after surgery and compare the 3D photos with the MRI data. No protected health information (PHI) will be shared with the University of Houston or other investigators.
During each clinic visit, relevant data will be extracted from Epic and entered manually into REDCap data forms by a member of the research team.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study.
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall | Experimental | Procedure: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), Procedure: 3-Dimensional (3-D) Photographs (Visit 1- 6), Procedure: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6), Procedure: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6), Procedure: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6)Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Planned autologous fat transfer or fat grafting reconstruction of the breast or chest wall.
- Able to provide written or electronic informed consent.
- Able to undergo MRI.
Key exclusion criteria (3 listed)
- Vulnerable subjects (children, prisoners, pregnant women).
- Patients who have active cancer, metastatic disease, solid organ transplantation / immunosuppression, or autoimmune diseases.
- Unable to undergo MRI (history of metal contraindication, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6)The study participant will be requested to stand upright with hands comfortably behind their back and turn 45 degrees and 90 degrees in either direction for standard anteroposterior (AP), oblique and lateral photos. Standardized photographic poses will be utilized so that only the participant's neck and torso will be visible and all jewelry on the neck and arms will be removed to eliminate potential identifiers. The photographs will be acquired using a commercially available camera or study iPad device. | Procedure or surgery | Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall |
| 3-Dimensional (3-D) Photographs (Visit 1- 6)3-Dimensional surface scans of the participant's torso will be acquired using a commercially available handheld camera scanning device that offers texture, geometry, and color acquisition from any complex surface using white light technology, which is safe for exposure to skin and eyes. Prior to imaging, a pattern of lines and dots will be marked on the patient's breasts using a washable marker. The study participant will be requested to sit upright on the exam room table with hands comfortably behind their back while the research staff member moves around their torso with the handheld scanner. The exam room table will then be reclined to a lay-flat position such that the patient is laying supine, and breast imaging will be repeated. Standardized photographic poses will be utilized so that only the participant's neck and torso will be visible and all jewelry on the neck and arms will be removed to eliminate potential identifiers. | Procedure or surgery | Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall |
| Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6)The images will be acquired using a commercially available handheld ultrasound scanning device. The study participant will be requested to sit upright on the exam room table with hands comfortably behind their back while the research staff member obtains images of the specific area of the breast of chest wall to be grafted (V1) and that which was grafted (V4-6). Images usually take 5-10 minutes to acquire depending on the number of areas grafted. | Procedure or surgery | Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall |
| Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6)An MRI of the breast will be obtained around visit 1 and visits 4-6 timepoints. The images will be acquired in collaboration with the Breast Imaging Core and the Magnetic Resonance Research Imaging Center. Dr. Abe (co-investigator, radiology) will review the images to assess volume of the overall breast, the specific areas of the breasts that were grafted. | Procedure or surgery | Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall |
| BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6)The BREAST-QTM measures three satisfaction domains and three quality of life (QoL) domains.6 For BREAST-QTM, each domain has a score range from 0 - 100. A difference in score, either positive or negative, of 10 points is considered clinically "important"; a difference of 20 points is considered clinically "very important." This survey will be administered to participants via iPad during visit 1 and visits 4-6 and takes approximately 10-20 minutes to complete. | Procedure or surgery | Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall |
Primary outcome
Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
Time frame: Visit 1through study completion, an average of 1 year
Images will be obtained from photographs, ultrasound, and MRI to compare and follow outcomes of autologous fat grafting to the chest for reconstruction and to visualize changes in the breast over time.
1 secondary outcome
Change from baseline in quality of life as measured by the BREAST-QTM survey.
Time frame: Visit 1through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Summer Hanson, MD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), 3-Dimensional (3-D) Photographs (Visit 1- 6) and Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6) in people with Autologous Fat Grafting, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summer Hanson, MD (773-702-6302, sehanson@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging. (time frame: Visit 1through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.