NCT04992650

Brief Summary

The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2021Aug 2026

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

April 1, 2021

Last Update Submit

December 9, 2025

Conditions

Breast ReconstructionRadiation DermatitisRadiation FibrosisFat Grafting

Outcome Measures

Primary Outcomes (1)

  • Radiation Fibrosis

    Number of subject to experience radiation fibrosis

    12 months

Study Arms (2)

Breast reconstruction with fat grafting

EXPERIMENTAL

fat grafting

Procedure: Fat grafting

breast reconstruction without fat grafting

NO INTERVENTION

No Fat grafting

Interventions

Fat graftingPROCEDURE

Fat grafting

Breast reconstruction with fat grafting

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
  • Have undergone mastectomy

You may not qualify if:

  • Patients who are unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

RadiodermatitisRadiation Fibrosis Syndrome

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and InjuriesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christin A. Harless, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

August 5, 2021

Study Start

March 1, 2021

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(1)