Back to resultsUltrasonic 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
About this trial
This is an interventional diagnostic trial for Breast Reconstruction
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
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
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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