Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Not Applicable

• Conditions: Breast Reconstruction; Radiation Fibrosis; Radiation Dermatitis; Fat Grafting
• Interventions: Procedure: Fat grafting

• Registration Number: NCT04992650
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

• Patients who are unwilling to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast reconstruction with fat grafting	Fat grafting	fat grafting

Primary Outcome Measures

Name	Time	Method
Radiation Fibrosis	12 months	Number of subject to experience radiation fibrosis

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States