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NCT04992650 Clinical Trial

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Breast Reconstruction Clinical Trial

Official title:
Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04992650
Other study ID # 20-001411
Secondary ID NCI-2021-08914
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 15, 2025

Study information
Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date June 15, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy - Have undergone mastectomy Exclusion Criteria: - Patients who are unwilling to participate

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fat grafting
Fat grafting

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiation Fibrosis Number of subject to experience radiation fibrosis 12 months
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