NCT07546331 · University of California, San Francisco
Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
What this study is about
This study compares measurements of body composition to outcomes of breast reconstruction.
View original scientific description
This study compares measurements of body composition to outcomes of breast reconstruction.
Interventions
PROCEDURE
Measurement of Body Composition
Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.
OTHER
Chart Review
Clinical and surgical data will be collected from the participants medical records.
Primary outcome measures
Proportion of Body Composition Measurement Collection
Time frame: up to 2 years
The proportion of enrolled participants with successfully obtained body composition measurements at both preoperative and postoperative timepoints. A success rate of ≥90% will be considered feasible. The proportion of the participants meets feasibility will be reported.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
- Age ≥ 18 years.
- Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap).
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breastfeeding.
- Patients assigned male at birth.
- Non-cisgender women.
- Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
- Patients with prosthetic limbs.
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations