Autologous Fat Grafting in Radiated Soft Tissue Reconstruction

NCT05890196 | Completed DMC

• 1 other identifier: IRB21-1183
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fat Grafting; Breast Cancer; Radiation Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Skin Fibrometry before and after fat transfer in reconstruction.

  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 Outcomes (2)

• Change in Radiation Injury before and after fat transfer.

  12 months

• Change in patient reported satisfaction of the breast measure before and after fat transfer.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

Summer E Hanson

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Pattani N, Sanghera J, Langridge BJ, Frommer ML, Abu-Hanna J, Butler P. Exploring the mechanisms behind autologous lipotransfer for radiation-induced fibrosis: A systematic review. PLoS One. 2024 Jan 25;19(1):e0292013. doi: 10.1371/journal.pone.0292013. eCollection 2024.

  PMID: 38271326 BACKGROUND

• Zheng M, Liu Z, He Y. Radiation-induced fibrosis: Mechanisms and therapeutic strategies from an immune microenvironment perspective. Immunology. 2024 Aug;172(4):533-546. doi: 10.1111/imm.13788. Epub 2024 Apr 1.

  PMID: 38561001 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Radiation Fibrosis Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 6, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)