Recruiting

Body Composition

Sponsor:

UCLA

Code:

NCT07546331

Conditions

Breast Carcinoma

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Measurement of Body Composition

Chart Review

Study Details

Brief summary:

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

Conditions

Breast Carcinoma

Breast Cancer

Study ID

NCT07546331

Start date

Feb 18, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A: Implant-based Reconstruction

Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.

Cohort B: Autologous Reconstruction

Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.

Interventions

Measurement of Body Composition

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

Chart Review

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

Primary outcome measure

  • Proportion of Body Composition Measurement Collection [ Time Frame: up to 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of California

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Merisa Piper, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Postmastectomy breast reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-22.