Skip to main content
OpenTrials
Completed

NCT Number: NCT05890196

Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fat Grafting Fibrosis Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Fibrosis Radiation Fibrosis Syndrome Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Summer E Hanson

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

A Pilot Study Treating Radiation Injury With Autologous Fat Transfer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.