Breast CancerNCT05890196
Autologous Fat Grafting in Radiated Soft Tissue Reconstruction
An observational study of Breast Cancer and Radiation Fibrosis, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Radiation Fibrosis, Fat Grafting
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Able to give consent
- Undergoing elective autologous fat grafting
- Previously treated for breast cancer
- Previous treatment included radiation therapy to the breast/chest wall.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
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.
Read the 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
- Medical subject headings
- Breast Neoplasms, Radiation Fibrosis Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Change in Radiation Injury before and after fat transfer.
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.
Measured: 12 months
Change in patient reported satisfaction of the breast measure before and after fat transfer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890196
- Sponsor's protocol ID
- IRB21-1183
- Status last verified
- Apr 2026
- First submitted
- 8 May 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38271326Zheng 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.
PubMed 38561001
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
- ClinicalTrials.gov ID
- NCT05890196
- Acronym / sponsor ID
- IRB21-1183
- Conditions
- Breast Cancer, Radiation Fibrosis, Fat Grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Able to give consent
- Undergoing elective autologous fat grafting
- Previously treated for breast cancer
- Previous treatment included radiation therapy to the breast/chest wall.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Change in Radiation Injury before and after fat transfer.
Time frame: 12 months
Change in patient reported satisfaction of the breast measure before and after fat transfer.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 38271326Pattani 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.
- Background: PubMed 38561001Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Fibrosis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Fibrometry before and after fat transfer in reconstruction. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.