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Tumor volume measurements vs diameter-based measurements (mRECIST) for response evaluation in pleural mesothelioma

COMET trial: Comparison of pleural mesothelioma evaluation using volume measurements with an artificial intelligence program to the mRECIST v1.1 criteria, a prospective trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12418979
Enrollment
52
Registered
2024-01-15
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural mesothelioma Cancer

Interventions

This is a prospective blinded comparative non-inferiority single-center feasibility study. Three radiologists will review every CT scan of adult patients with pleural mesothelioma referred to the tert

Sponsors

Antoni van Leeuwenhoek Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histology or cytology-proven non-resectable pleural mesothelioma 2. Age =18 years 3. Availability of a baseline CT thorax with contrast before the start of new systemic treatment with a slice increment of =3 mm on the CT scan 4. Availability of at least one follow-up scan (the lungs must be fully contained in the image)

Exclusion criteria

Exclusion criteria: 1. CT scans with lungs not fully imaged 2. No histology-proven pleural mesothelioma

Design outcomes

Primary

MeasureTime frame
The interobserver agreement among experts employing the ARTIMES criteria and the gold standard (mRECIST v1.1 criteria), measured at the end of the study using kappa

Secondary

MeasureTime frame
1. Time needed to measure response evaluation in minutes between the ARTIMES vs mRECIST v1.1 criteria, measured in minutes for every scan at every evaluation point 2. Time until partial response (PR) and progressive disease (PD) in days between the ARTIMES vs mRECIST v1.1 criteria, measured in days at every evaluation point 3. The response evaluation of the treating physician with the ARTIMES criteria and the mRECIST v1.1. criteria per evaluation point, compared at every evaluation point 4. The performance of the AI in segmenting pleural mesothelioma tumour volume vs the final segmentation of the reviewers, compared at every evaluation point

Countries

Netherlands

Contacts

Public ContactIllaa Smesseim
i.smesseim@nki.nl+31 (0)205129111

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026