Enrolling by invitation NCT04992650

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

No phase Interventional Breast Reconstruction Radiation Dermatitis Radiation Fibrosis Fat Grafting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Fat grafting.
Who it may be relevant to: Registry conditions: Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis, Fat Grafting. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

Procedure Fat grafting
Fat grafting

Primary outcome measures

Radiation Fibrosis [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Diagnostic

Study locations

United States · 1 center

Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT04992650 · 20-001411

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗