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Validation of a Body-Composition Segmentation Software on a Diverse Public CT Scan Cohort (SOMA)

15 mai 2026 mis à jour par: Nucleo Research, Inc.

Validation of a Body-Composition Segmentation Software (Soma) on a Diverse Cohort of Publicly Available CT Scans

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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Background. Body composition derived from cross-sectional imaging is increasingly used to assess sarcopenia, cachexia, and metabolic risk across oncology, surgical, and metabolic conditions. Manual segmentation at the L3 vertebra is the established reference but is time-consuming and rater-dependent. Soma is a deep-learning software pipeline (U-Net segmentation of skeletal muscle, subcutaneous adipose tissue, visceral adipose tissue, and intramuscular adipose tissue; EfficientNet-Lite0 + BiLSTM for automated L3 slice detection) developed by Nucleo Research, Inc. to provide reproducible, automated body-composition measurements from routine abdominal CT.

Objective. To validate the standalone segmentation performance of Soma against an expert multi-rater reference standard, in aggregate and across predefined demographic and clinical subgroups.

Design. Retrospective, multi-source observational validation on 200 de-identified abdominal CT scans, drawn by stratified sampling from a curated pool of 2,066 scans across six publicly available datasets (autoPET, AMOS, MSD Pancreas, CT-ORG, ENHANCE.PET, RATIC). Stratification ensures representation across: BMI category (4 levels), age band (4 levels), sex (2 levels), body region (abdomen-only vs. whole-body), and clinical context (oncologic vs. non-oncologic).

Reference Standard. Three board-certified radiologists independently annotate the four tissue classes on every fifth axial slice (stride of 5) across the full scan depth. Inter-rater agreement is summarized prior to consolidation; consensus reference is derived per pre-specified consolidation rules.

Index Test. Soma processes each scan blinded to ground truth. Outputs include per-tissue segmentation masks, tissue cross-sectional areas, and downstream indices including Skeletal Muscle Index (SMI = muscle area / height^2).

Primary Endpoint. Mean Dice similarity coefficient between Soma and the multi-rater reference computed across all annotated slices, with predefined performance thresholds: greater than or equal to 0.90 for muscle, subcutaneous adipose, and visceral adipose tissues; greater than or equal to 0.85 for intramuscular adipose tissue. Thresholds must be met both in aggregate AND within every demographic or clinical subgroup with at least 20 scans. 95% bias-corrected and accelerated (BCa) bootstrap confidence intervals are reported.

Secondary Endpoints. (1) Bland-Altman analysis of agreement on tissue cross-sectional areas (bias and 95% limits of agreement). (2) 95th-percentile Hausdorff distance per tissue class. (3) Pearson correlation coefficient for tissue areas and SMI. (4) Cohen's kappa for sarcopenia classification (binary, by sex-specific SMI cutoffs) with prespecified threshold of greater than or equal to 0.80.

Safety, Privacy, and Ethics. The study is fully retrospective on previously collected, publicly available, de-identified imaging data, with no patient contact and no intervention. There is no foreseeable risk to subjects. The protocol has been determined exempt by Salus IRB (Salus Number 26328) under 45 CFR 46.104(d)(4) on 04 May 2026.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • San Francisco, California, États-Unis, 94133

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Subjects older than 16 years old whose de-identified abdominal CT imaging is available from one of six publicly accessible imaging datasets (autoPET, AMOS, MSD Pancreas, CT-ORG, ENHANCE.PET, RATIC). The 200-scan study cohort is selected by stratified sampling from a curated pool of 2,066 scans to ensure representation across BMI category, age band, sex, body region (abdomen-only vs. whole-body), and clinical context (oncologic vs. non-oncologic).

La description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subject under 16 years of age at the time the source imaging was acquired.
  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Public CT Validation Cohort
Two hundred de-identified abdominal CT scans selected by stratified sampling from a curated pool of 2,066 scans aggregated across six publicly available imaging datasets (autoPET, AMOS, MSD Pancreas, CT-ORG, ENHANCE.PET, RATIC). Stratification covers BMI category, age band, sex, body region (abdomen-only vs. whole-body), and clinical context (oncologic vs. non-oncologic). Each scan is processed by the Soma software (index test) and independently annotated on every fifth axial slice across the full scan depth by three board-certified radiologists (reference standard).
Test diagnostique: Soma Body-Composition Segmentation Software
Soma is a deep-learning software pipeline developed by Nucleo Research, Inc. for the automated quantitative analysis of body composition from abdominal CT. It comprises (i) a U-Net segmentation model that delineates skeletal muscle, subcutaneous adipose tissue, visceral adipose tissue, and intramuscular adipose tissue on each axial CT slice; and (ii) an EfficientNet-Lite0 + BiLSTM model for automated L3 vertebra detection from axial CT volumes. In this validation study, segmentation performance is assessed on every fifth axial slice across the full scan depth. Outputs include per-tissue segmentation masks, tissue cross-sectional areas (cm^2), and derived indices including the Skeletal Muscle Index (SMI = muscle area / height^2). In this study, Soma is applied as the index test in standalone mode, fully blinded to the multi-rater radiologist reference standard.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dice Similarity Coefficient (DSC) of Soma Segmentation Versus Multi-Rater Radiologist Reference Standard
Délai: Single time point: completion of standalone Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Mean Dice Similarity Coefficient (DSC) between Soma-generated segmentation masks and the consensus reference from three board-certified radiologists, computed per tissue class (skeletal muscle, subcutaneous adipose tissue, visceral adipose tissue, intramuscular adipose tissue) on all annotated axial slices (every fifth slice across the full scan depth). Predefined performance thresholds: mean DSC greater than or equal to 0.90 for skeletal muscle, subcutaneous adipose, and visceral adipose tissues; mean DSC greater than or equal to 0.85 for intramuscular adipose tissue. Thresholds must be met both in aggregate and within every demographic and clinical subgroup with at least 20 scans (BMI category, age band, sex, body region, clinical context). Reported with 95% bias-corrected and accelerated (BCa) bootstrap confidence intervals.
Single time point: completion of standalone Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Bland-Altman Agreement for Tissue Cross-Sectional Areas (cm^2)
Délai: Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Bland-Altman analysis comparing tissue cross-sectional areas (in cm^2) computed by Soma versus the multi-rater radiologist reference, for each tissue class (skeletal muscle, subcutaneous adipose, visceral adipose, intramuscular adipose). Reported: mean bias and 95% limits of agreement, in aggregate and within demographic and clinical subgroups.
Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
95th-Percentile Hausdorff Distance Per Tissue Class
Délai: Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
95th-percentile Hausdorff distance (HD95, in mm) between Soma segmentation contours and the multi-rater radiologist reference, computed per tissue class at the L3 vertebra. Reported in aggregate and within demographic and clinical subgroups.
Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Pearson Correlation of Tissue Areas and Skeletal Muscle Index (SMI)
Délai: Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Pearson correlation coefficient (r) between Soma-derived and multi-rater-reference values for: (i) per-tissue cross-sectional areas (skeletal muscle, subcutaneous adipose, visceral adipose, intramuscular adipose, in cm^2); and (ii) Skeletal Muscle Index (SMI = skeletal muscle area / height^2, in cm^2/m^2). Reported with 95% confidence intervals, in aggregate and within subgroups.
Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Cohen's Kappa for Sarcopenia Classification by Skeletal Muscle Index (SMI)
Délai: Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.
Cohen's kappa coefficient quantifying agreement between Soma-derived and reference-derived binary sarcopenia classification, defined by sex-specific Skeletal Muscle Index (SMI) cutoffs. Prespecified performance threshold: kappa greater than or equal to 0.80. Reported in aggregate and within demographic and clinical subgroups.
Single time point: completion of Soma inference and consolidated multi-rater annotation on all 200 study scans, anticipated within two weeks of study start.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nucleo Research, Inc.

Les enquêteurs

  • Chercheur principal: Luca Pegolotti, Nucleo Research, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 mai 2026

Achèvement primaire (Estimé)

15 juin 2026

Achèvement de l'étude (Estimé)

15 juin 2026

Dates d'inscription aux études

Première soumission

15 mai 2026

Première soumission répondant aux critères de contrôle qualité

15 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SOMA-26328

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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