Clinical trial · Observational
Autologous Fat Grafting in Radiated Soft Tissue Reconstruction
A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
NCT05890196CI-TRIAL-00109250completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fat Grafting | — | UNRESOLVED | — |
| Radiation Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Skin Fibrometry before and after fat transfer in reconstruction.
- timeFrame
- 12 months
- description
- 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 (2)
- measure
- Change in Radiation Injury before and after fat transfer.
- timeFrame
- 12 months
- description
- 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.
- measure
- Change in patient reported satisfaction of the breast measure before and after fat transfer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDPattani 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
- BACKGROUNDZheng 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