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Autologous Fat Transfer for Breast Reconstruction

N/A

Recruiting

Led By Summer Hanson, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18 years or older

Planned autologous fat transfer or fat grafting reconstruction of the breast or chest wall

Must not have

Patients who have active cancer, metastatic disease, solid organ transplantation / immunosuppression, or autoimmune diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the outcomes of patients who undergo autologous fat transfer for breast or chest wall reconstruction. Patients will have photographs taken, complete a questionnaire, and undergo imaging tests such as MRI

Who is the study for?

This trial is for adults over 18 planning to have fat transferred from one part of their body to reconstruct the breast or chest wall. They must be able to give consent and undergo MRI scans.

What is being tested?

The study tests how well autologous fat transfer works for reconstruction by using MRI, ultrasound, and both 2-D and 3-D photos before and after the procedure. It also measures patient satisfaction through a questionnaire.

What are the potential side effects?

Since this trial focuses on assessment rather than treatment, it does not directly involve side effects of interventions; however, standard risks associated with MRI imaging may apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am planning to have breast or chest wall reconstruction using my own fat.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active cancer, metastatic disease, or an autoimmune condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.

Secondary study objectives

Change from baseline in quality of life as measured by the BREAST-QTM survey.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients Receiving Autologous Fat Transfer of the Breast or Chest WallExperimental Treatment5 Interventions

Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study.

0 / 3Eligibility criteria met