Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

Mayo Clinic

Status: Invitation-only

Conditions: Breast Reconstruction; Radiation Fibrosis; Fat Grafting; Radiation Dermatitis

Treatments: Procedure: Fat grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT04992650

NCI-2021-08914 (Registry Identifier)

20-001411

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Breast reconstruction with fat grafting

Experimental group

Description:

fat grafting

Treatment:

Procedure: Fat grafting

breast reconstruction without fat grafting

No Intervention group

Description:

No Fat grafting