Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

Trial Title: Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

NCT ID: NCT05890196

Condition: Breast Cancer
Radiation Fibrosis
Fat Grafting

Conditions: Official terms:
Radiation Fibrosis Syndrome

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Summer E Hanson

Address:
City: Chicago
Zip: 60637
Country: United States

Start date: March 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: University of Chicago
Agency class: Other

Source: University of Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05890196