Clinical trial · Observational
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
NCT07546331CI-TRIAL-00109131recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares measurements of body composition to outcomes of breast reconstruction.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chart Review | Other | — | UNRESOLVED |
| Measurement of Body Composition | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: Implant-based Reconstruction
- description
- Patients undergo standard of care implant-based breast reconstruction and body composition measurement on study.
- interventionNames
- Procedure: Measurement of Body Composition
- Other: Chart Review
- label
- Cohort B: Autologous Reconstruction
- description
- Patients undergo standard of care autologous breast reconstruction and body composition measurement on study.
- interventionNames
- Procedure: Measurement of Body Composition
- Other: Chart Review
Primary outcomes (1)
- measure
- Proportion of Body Composition Measurement Collection
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.