Quantitative Assessment of Autologous Fat Transfer

Conditions

• Autologous Fat Grafting

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.
• 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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Jan 25, 2024

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

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.

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

• Summer Hanson, MD
  773-702-6302
  [email protected]

Locations (2)

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