Tumor volume measurements vs diameter-based measurements (mRECIST) for response evaluation in pleural mesothelioma
| ISRCTN | ISRCTN12418979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12418979 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IRBd23-265 |
| Sponsor | Antoni van Leeuwenhoek Hospital |
| Funder | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
- Submission date
- 31/12/2023
- Registration date
- 15/01/2024
- Last edited
- 15/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Pleural mesothelioma (PM) is an aggressive type of cancer that arises from the pleural mesothelium, a thin layer covering the lungs and chest wall. The aim of this study is to investigate whether using the tumour volume makes the response evaluation more reliable compared to the current mRECIST criteria (diameter-based measurements).
Who can participate?
Patients aged 18 years and over with pleural mesothelioma
What does the study involve?
All patients will be treated by their own treating physician. However, during this study, an additional response evaluation based on tumor volume will be conducted. Treatment decisions will not be based on this evaluation.
What are the possible benefits and risks of participating?
There are no side effects nor possible benefits for the patients when participating. The researchers will gain more knowledge about the response evaluation system.
Where is the study run from?
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (Netherlands)
When is the study starting and how long is it expected to run for?
June 2023 to December 2025
Who is funding the study?
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (Netherlands)
Who is the main contact?
Sjaak Burgers, s.burgers@nki.nl
Contact information
Public, Scientific
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 (0)205129111 |
|---|---|
| i.smesseim@nki.nl |
Principal investigator
Thoracic Oncology / Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 (0)644137161 |
|---|---|
| s.burgers@nki.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective blinded comparative non-inferiority single-centre feasibility study |
| Secondary study design | Feasibility study |
| Study type | Participant information sheet |
| Scientific title | COMET trial: Comparison of pleural mesothelioma evaluation using volume measurements with an artificial intelligence program to the mRECIST v1.1 criteria, a prospective trial |
| Study acronym | COMET |
| Study objectives | ARTIMES yields an equal or higher interobserver agreement between different radiologists compared to mRECIST v1.1. |
| Ethics approval(s) |
Approved 04/12/2023, Institutional Review Board (IRB) The Netherlands Cancer Institute (Plesmanlaan 121, Amsterdam, 1066 CX, Netherlands; +31 (0)20 51291; IRB@nki.nl), ref: IRBd23-265 |
| Health condition(s) or problem(s) studied | Pleural mesothelioma |
| Intervention | 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 tertiary center according to the mRECIST v1.1 and ARTIMES. Confirmation bias could occur if a radiologist assigns progressive disease (PD) following mRECIST v1.1 and is afterwards segmenting extra volume to ensure a PD for ARTIMES as well. To reduce this bias, the same CT scan needs to be reviewed for mRECIST and ARTIMES on different days with a washout of at least 4 weeks. The sequence in which both methods are used will be random. Reviewers will be blinded for their own results and for the results of the other reviewers. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 52 |
| Key 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) |
| Key exclusion criteria | 1. CT scans with lungs not fully imaged 2. No histology-proven pleural mesothelioma |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 01/01/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1066 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data will be stored for at least 20 years and as long as proven useful for scientific research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/01/2024: Study's existence confirmed by the Institutional Review Board (IRB) The Netherlands Cancer Institute.
