Quantitative Assessment of Autologous Fat Transfer

The University of Chicago

Status: Enrolling

Conditions: Autologous Fat Grafting

Treatments: Procedure: 3-Dimensional (3-D) Photographs (Visit 1- 6); Procedure: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6); Procedure: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6); 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)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06343831

IRB23-1646

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

Experimental group

Description:

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.

Treatment:

Procedure: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6)

Procedure: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6)

Procedure: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6)

Procedure: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6)

Procedure: 3-Dimensional (3-D) Photographs (Visit 1- 6)