Quantitative Assessment of Autologous Fat Transfer for Breast Reconstruction

This study is looking at how well different imaging methods (like photographs, ultrasound, and MRI) can track changes in the breast after autologous fat transfer (fat grafting) for reconstruction. Researchers will compare 2-D and 3-D photographs, ultrasound, and MRI scans to see how the breast changes over time. You would also complete a questionnaire (BREAST-Q™) to share your satisfaction and quality of life. The study aims to enroll 15 adults aged 18 or older who are planning to have autologous fat transfer for breast or chest wall reconstruction and can undergo an MRI. The main goal is to measure changes in breast/chest wall volume using imaging from the start of the study through about one year.

Study design
This is a single-arm pilot study, meaning all participants will receive the same intervention. It plans to enroll 15 participants.
What's involved
You would have several visits, including pre-operative appointments and follow-up visits. These visits involve 2-D and 3-D photographs, ultrasound, MRI scans, and completing a questionnaire.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from Visit 1 through study completion, which is an average of one year.

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NCT06343831

Quantitative Assessment of Autologous Fat Transfer

Recruiting
NAAges 18+Interventional
University of Chicago
~15 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested: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)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
Measured over Visit 1through study completion, an average of 1 year
Autologous Fat Grafting
2 sites across 2 states
Illinois1
Texas1
  • Summer Hanson, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)
  • Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.Visit 1through study completion, an average of 1 year

    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.