Recruiting
Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
This study compares measurements of body composition to outcomes of breast reconstruction.
ClinicalTrials.gov IDNCT07546331
PhaseNot Applicable
Enrollment40
SponsorUniversity of California, San Francisco
Age18 Years
SexALL
Conditions studied
Breast Carcinoma, Breast Cancer
About this study
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 outcomes
- Proportion of Body Composition Measurement Collection (up to 2 years)
Eligibility information
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
- University of California, San Francisco, California 94143 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.