Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Carcinoma
• Intervention / Treatment: Procedure: Measurement of Body Composition; Other: Chart Review

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Michael Choi; Phone Number: 877-827-3222; Email: Michael.Choi@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California
      • Principal Investigator: Merisa Piper, MD
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
      • Contact: Michael Choi; Phone Number: 877-827-3222; Email: Michael.Choi@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants seen at University California of San Francisco (UCSF) clinics

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A: Implant-based Reconstruction; Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.	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.
Cohort B: Autologous Reconstruction; Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Variability of Body Composition	To investigate how body fat measurements change after surgery and how consistent these measurements are when repeated.	up to 2 years
Pre- to Postoperative Changes in Body Composition and Their Association with BMI	Associations between body fat parameters and changes in BMI will be evaluated using correlative analyses.	up to 2 years
Association Between Body Composition Parameters and Postoperative Complications Following Breast Reconstruction	The association between body composition parameters and postoperative complications following breast reconstruction will be examined. Complications of interest include infection, seroma, hematoma, delayed wound healing, and tissue necrosis.	up to 2 years

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Merisas Piper, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postmastectomy breast reconstruction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 25759; NCI-2026-01299 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No