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RecruitingObservational

Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction

NCT ID: NCT07546331Sponsor: University of California, San FranciscoLast updated: 2026-04-22

Summary

This study compares measurements of body composition to outcomes of breast reconstruction.

Detailed description

PRIMARY OBJECTIVES: 1\. Determine feasibility of collecting measurements of body composition. SECONDARY OBJECTIVES: 1. Define the differences in body composition between participants undergoing breast reconstruction who develop complications and those who do not. 2. To determine the implications of different measures of body composition on outcomes of breast reconstruction. 3. Compare utility of body composition measurements versus other anthropometric assessments on assessing risk of complications following breast surgery. OUTLINE: This is a observational study. Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years.

Arms & interventions

  • ProcedureMeasurement of Body Composition

    Body composition measurements collected pre and post operatively using a bioelectrical impedance analyzer.

  • OtherChart Review

    Clinical and surgical data will be collected from the participants medical records.

Outcome measures

Primary

  • Proportion of Body Composition Measurement Collection

    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.

    Time frame: up to 2 years

Secondary

  • Postoperative Variability of Body Composition

    Time frame: up to 2 years

  • Pre- to Postoperative Changes in Body Composition and Their Association with BMI

    Time frame: up to 2 years

  • Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction

    Time frame: up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy. 2. Age ≥ 18 years. 3. 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). 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 2. Pregnant or breastfeeding. 3. Patients assigned male at birth. 4. Non-cisgender women. 5. Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator). 6. Patients with prosthetic limbs.

Study locations (1)

University of California

San Francisco, California, 94143

Recruiting
Michael Choi · Contact
877-827-3222Michael.Choi@ucsf.edu
· Contact
877-827-3222cancertrials@ucsf.edu
Merisa Piper, MD · Principal Investigator
Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction | Cancerify