Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

April 20, 2026 updated by: University of Chicago

A Pilot Study Treating Radiation Injury With Autologous Fat Transfer

The purpose of this study is to observe the effect of autologous fat grafting on soft tissue reconstruction of the breast following radiation treatment. Moving fat from one part of the body to another has been used for reconstruction for hundreds of years. However, it is not fully understood how well this works in reconstruction after radiation is used for cancer treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing AFT for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. As this is a pilot study, the study team plans to enroll ten (10) patients to demonstrate the feasibility of the protocol and pathway as well as establish preliminary data for extramural funding. The research will include capturing 2-dimensional (2-D) and 3-dimensional (3-D) photographs as well as ultrasound (US) soft tissue assessments to determine volume retention and changes in the reconstructed area. Participants will undergo this imaging of their breast and chest wall and complete two questionnaires to evaluate patient satisfaction, quality of life, and late effects of radiation following fat grafting over a 12-month period, all standard of care. The 3D photographs and US are routinely used in practice but will be performed for research purposes in this study.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Summer E Hanson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll participants from the University of Chicago who are undergoing autologous fat grafting as part of their reconstruction for breast cancer.

Description

Inclusion Criteria:

  • Able to give consent
  • Undergoing elective autologous fat grafting
  • Previously treated for breast cancer
  • Previous treatment included radiation therapy to the breast/chest wall.

Exclusion Criteria:

  • Unable to give consent
  • No history of radiation to the breast or chest wall
  • No prior treatment for breast cancer
  • No indication for autologous fat grafting
  • Currently pregnant or breastfeeding
  • Currently consuming nicotine products (smoking, vaping, patches, gum)
  • Under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Fibrometry before and after fat transfer in reconstruction.
Time Frame: 12 months
Soft tissue assessment is made using a non-invasive device SkinFibrometer (Delfin Kuopio, Finland) that measures tissue edema and skin elasticity. Measurements will be taken in all four quadrants of the affected (radiated) breast or reconstructed breast before and after the grafting procedure.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Radiation Injury before and after fat transfer.
Time Frame: 12 months
Radiation injury assessment is made using the validated tool Late Effects Normal Tissue Task Force - Subjective Objective Management and Analytic (LENT-SOMA) score. Assessment will be made before and after the fat transfer procedure. Overall, scores are based on 12 categories, scored 0-4 with a higher score indicating more significant radiation injury.
12 months
Change in patient reported satisfaction of the breast measure before and after fat transfer.
Time Frame: 12 months
The BREAST Q validated patient survey measures several realms related to breast reconstruction and allows an assessment of satisfaction and physical well-being before and after reconstruction. The survery responses are tallied and converted to a score of 100 with a higher score being more satisfied or better outcome. In addition, a change in score of 8 or more points is a clinically meaningful difference according to normative studies.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB21-1183

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe