Clinical trial NCT06343831: Quantitative Assessment of Autologous Fat Transfer
Official title: Quantitative Assessment of Autologous Fat Transfer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autologous Fat Grafting
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Houston
First posted: 2024-04-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
timeFrame: Visit 1through study completion, an average of 1 year
Secondary outcomes:
measure: Change from baseline in quality of life as measured by the BREAST-QTM survey.
timeFrame: Visit 1through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Houston
country: United States
facility: The University of Houston
state: Texas
Study officials:
affiliation: University of Chicago
name: Summer Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References: