ClinicalTrials.gg
Enrolling by invitationNCT04992650Updated Jun 1, 2026

Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

An interventional study of Fat grafting in Breast Reconstruction, Radiation Dermatitis and Radiation Fibrosis, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

02

Conditions studied

  • Breast Reconstruction
  • Radiation Dermatitis
  • Radiation Fibrosis
  • Fat Grafting
03

In context

Radiodermatitis

127 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.

This study's planned enrollment of 15 is below the median of 55 across 104 interventional studies indexed under Radiodermatitis.

Browse Radiodermatitis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
  • Have undergone mastectomy

Exclusion criteria

Exclusion Criteria:

  • Patients who are unwilling to participate
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Breast reconstruction with fat grafting

    fat grafting

    Procedure: Fat grafting

  • No intervention
    breast reconstruction without fat grafting

    No Fat grafting

Interventions

  • ProcedureFat grafting

    Fat grafting

06

What researchers measure

Primary outcomes

  1. Radiation Fibrosis

    Number of subject to experience radiation fibrosis

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04992650
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Mar 1, 2021
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Jun 1, 2026

Study contacts

Christin A. Harless, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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