Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction
Recruiting · NCT07546331 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Chart ReviewMeasurement of Body Composition
What this trial is about
This study compares measurements of body composition to outcomes of breast reconstruction.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy.
- Age ≥ 18 years.
- 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).
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breastfeeding.
- Patients assigned male at birth.
- Non-cisgender women.
- Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator).
- Patients with prosthetic limbs.
Where it is running
1 location listed across 1 US state.
- University of California - San Francisco, California, United States