NCT05890196

Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

A Pilot Study Treating Radiation Injury With Autologous Fat Transfer

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer
• Radiation Fibrosis
• Fat Grafting

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-06-06
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States