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Fat Grafting for Breast Reconstruction
N/A
Waitlist Available
Led By Christin A Harless, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
Have undergone mastectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is measuring the effects of radiation and fat grafting on blood flow to post-mastectomy skin.
Who is the study for?
This trial is for breast cancer patients who have had a mastectomy and are undergoing immediate reconstruction with tissue expanders or implants that require radiation therapy. It's not open to those who do not wish to participate.Check my eligibility
What is being tested?
The study is looking at how well blood flows through the skin of the breast after it has been treated with radiation and then fat grafting. This will help understand if fat grafting improves skin condition post-radiation.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks associated with fat grafting may include infection, bleeding, or changes in sensation around the treatment area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a breast cancer patient getting an implant or tissue expander with planned radiation therapy.
Select...
I have had a mastectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiation Fibrosis
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Breast reconstruction with fat graftingExperimental Treatment1 Intervention
fat grafting
Group II: breast reconstruction without fat graftingActive Control1 Intervention
No Fat grafting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fat grafting
2011
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,734 Total Patients Enrolled
Christin A Harless, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a breast cancer patient getting an implant or tissue expander with planned radiation therapy.I have had a mastectomy.I am willing to participate in the clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Breast reconstruction with fat grafting
- Group 2: breast reconstruction without fat grafting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor still accepting participants?
"The information on clinicaltrials.gov indicates that this trial is not presently enrolling patients; the study was initially published on March 1st 2021 and its status last changed in December of that same year. However, there are currently 262 other medical trials searching for participants."
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