Quantitative Assessment of Autologous Fat Transfer

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 25, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Autologous Fat Grafting
Interventions
PROCEDURE

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

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

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

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

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."

Trial Locations (2)

60637

RECRUITING

The University of Chicago, Chicago

77204

RECRUITING

The University of Houston, Houston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

University of Houston

OTHER

lead

University of Chicago

OTHER