Recruiting

Autologous Fat Transfer

Sponsor:

University of Chicago

Code:

NCT06343831

Conditions

Autologous Fat Grafting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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)

Study Details

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.

Conditions

Autologous Fat Grafting

Study ID

NCT06343831

Start date

Jan 25, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

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.

Interventions

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.

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.

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.

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.

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.

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 ]

Central Contacts and Locations

Central contacts

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

The University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Principal Investigator:

Fatima Merchant, Ph.D

More Information

Sponsor

University of Chicago

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-10.