Validation of a Body-Composition Segmentation Software on a Diverse Public CT Scan Cohort
Public ClinicalTrials.gov record NCT07600866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Validation of a Body-Composition Segmentation Software (Soma) on a Diverse Cohort of Publicly Available CT Scans
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluates the standalone performance of Soma, a deep-learning software developed by Nucleo Research, Inc. for the automated segmentation of body-composition tissues (skeletal muscle, subcutaneous adipose tissue, visceral adipose tissue, and intramuscular adipose tissue) on whole-body computed tomography (CT) images. The aim is to confirm that Soma produces segmentations and tissue-area measurements that agree with a multi-rater expert reference standard, on a diverse cohort representative of demographic and clinical variation. A total of 200 CT scans are sampled by stratified design from a curated pool of 2,066 scans aggregated from six publicly available, de-identified imaging datasets (autoPET, AMOS, MSD Pancreas, CT-ORG, ENHANCE.PET, RATIC). Three board-certified radiologists independently annotate the reference standard at the L3 slice. Primary performance is assessed using the Dice similarity coefficient against the multi-rater reference, with predefined thresholds and BCa bootstrap confidence intervals, both in aggregate and within every demographic and clinical subgroup. Secondary endpoints include Bland-Altman analysis of tissue-area agreement, 95th-percentile Hausdorff distance, Pearson correlation of derived indices, and Cohen's kappa for sarcopenia classification using Skeletal Muscle Index (SMI). The study is fully retrospective on de-identified images, involves no patient contact, and has been determined exempt by Salus IRB (Salus Number 26328) under 45 CFR 46.104(d)(4).
Study identification
- NCT ID
- NCT07600866
- Recruitment status
- Not yet recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2026
- Primary completion
- Jun 14, 2026
- Completion
- Jun 14, 2026
- Last update posted
- May 21, 2026
2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nucleo Research, Inc. | San Francisco | California | 94133 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07600866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07600866 live on ClinicalTrials.gov.