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Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Primary Purpose

Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fat grafting
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breast reconstruction with fat grafting

breast reconstruction without fat grafting

Arm Description

fat grafting

No Fat grafting

Outcomes

Primary Outcome Measures

Radiation Fibrosis
Number of subject to experience radiation fibrosis

Secondary Outcome Measures

Full Information

First Posted
April 1, 2021
Last Updated
June 28, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04992650
Brief Title
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients
Official Title
Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis, Fat Grafting

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast reconstruction with fat grafting
Arm Type
Experimental
Arm Description
fat grafting
Arm Title
breast reconstruction without fat grafting
Arm Type
No Intervention
Arm Description
No Fat grafting
Intervention Type
Procedure
Intervention Name(s)
Fat grafting
Intervention Description
Fat grafting
Primary Outcome Measure Information:
Title
Radiation Fibrosis
Description
Number of subject to experience radiation fibrosis
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christin A Harless, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

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