Quantitative Assessment of Autologous Fat Transfer

NCT06343831 | Recruiting

• 1 other identifier: IRB23-1646
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Visit 1through study completion, an average of 1 year.

Study Arms (1)

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.

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)

Interventions

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

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.

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

3-Dimensional (3-D) Photographs (Visit 1- 6) PROCEDURE

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.

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

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

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.

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

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

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.

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

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

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.

Patients Receiving Autologous Fat Transfer of the Breast or Chest Wall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• National Institutes of Health (NIH): collaborator
• University of Houston: collaborator

Study Sites (2)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

The University of Houston

Houston, Texas, 77204, United States

RECRUITING

Study Officials

• Summer Hanson, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Hanson, MD

CONTACT

773-702-6302; sehanson@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 3, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (2)