Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

June 28, 2023 updated by: Christin A. Harless, Mayo Clinic

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast reconstruction with fat grafting
fat grafting
Procedure: Fat grafting
Fat grafting
No Intervention: breast reconstruction without fat grafting
No Fat grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Fibrosis
Time Frame: 12 months
Number of subject to experience radiation fibrosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christin A Harless, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-001411
  • NCI-2021-08914 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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