Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04992650
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 1.9

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction; Radiation Dermatitis; Radiation Fibrosis; Fat Grafting	Procedure: Fat grafting	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Radiation Fibrosis [12 months]

   Number of subject to experience radiation fibrosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Christin A. Harless, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04992650
• Other Study ID Numbers: 20-001411
• First Posted: Aug 5, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Radiation Pneumonitis; Dermatitis; Radiodermatitis

Study Results

No Results Posted as of Dec 2, 2021