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Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

NCT ID: NCT04992650

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-08-15

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Reconstruction Radiation Dermatitis Radiation Fibrosis Fat Grafting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Breast reconstruction with fat grafting

fat grafting

Group Type EXPERIMENTAL

Fat grafting

Intervention Type PROCEDURE

Fat grafting

breast reconstruction without fat grafting

No Fat grafting

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fat grafting

Fat grafting

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christin A. Harless, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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NCI-2021-08914

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-001411

Identifier Type: -

Identifier Source: org_study_id