Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Merisas Piper, MD (ucsf)

Description

Summary

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

Official Title

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

Details

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.

Keywords

Breast Carcinoma, Breast Cancer, Postmastectomy breast reconstruction, Breast Neoplasms, Measurement of Body Composition, Chart Review, Implant-based Reconstruction, Autologous Reconstruction

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • University of California accepting new patients
    San Francisco California 94143 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07546331
Study Type
Observational
Participants
Expecting 40 study participants
Last Updated