NCT07600866Not yet recruiting
Validation of a Body-Composition Segmentation Software on a Diverse Public CT Scan Cohort
Validation of a Body-Composition Segmentation Software (Soma) on a Diverse Cohort of Publicly Available CT Scans
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 15 May 2026
- Start date
- 31 May 2026
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Nucleo Research, Inc.
- Diseases
- Obesity
- NCT number
- NCT07600866
What you commit to
- Study type: Observational
- Planned participants: 200
- From 31 May 2026 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Subject under 16 years of age at the time the source imaging was acquired.
Other
- Scan does not include the L3 vertebra or has severe motion artifact, truncation, or metallic artifact precluding analysis at the L3 level.
- Duplicate or near-duplicate scans of the same subject already included in the cohort.
- Missing demographic metadata required for at least one stratification axis.
Who the study is looking for
- Subjects above 16 years or older at the time the source imaging was acquired.
- De-identified abdominal computed tomography (CT) scan available from one of the six predefined publicly available datasets (autoPET, AMOS, MSD Pancreas, CT-ORG, ENHANCE.PET, or RATIC).
- Scan covers the third lumbar vertebra (L3) with a contiguous axial slice suitable for L3-level body-composition analysis.
- Demographic metadata required for stratified sampling (age, sex; BMI where available; clinical context as encoded in source dataset) is present.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleo Research, Inc. Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.