Italian Imaging-Meso Study Maps the Mesothelioma Immune Map
Imaging-Meso profiles the immune microenvironment and gene expression of pleural and peritoneal mesothelioma. NCT06581549 is recruiting in Italy.
An observational study in Italy is collecting tumor tissue from people with pleural and peritoneal mesothelioma to read the immune and genetic makeup of the disease in fine detail. The goal is to sort patients into molecular subgroups that could one day guide more personalized treatment.
The Imaging-Meso study (NCT06581549) is led by Istituto Oncologico Veneto IRCCS and is recruiting at 10 Italian centers. It is not a drug trial. No experimental treatment is given as part of the study. Instead, researchers analyze tumor samples with gene expression profiling, spatial whole transcriptome analysis, and multiplex immunofluorescence to characterize each tumor’s biology and its immune environment. The study plans to enroll 220 people.
What the Study Is Testing
Pleural and peritoneal mesotheliomas are rare cancers, mostly linked to asbestos exposure, with few treatment options and a difficult prognosis. According to the study record, the main unmet need is the lack of a clear treatment sequence for patients. The study’s stated aim is to improve how these cancers are stratified by their immune-biological and molecular features, so that different patient subgroups might eventually be matched to different treatment approaches.
To do that, the researchers collect treatment-naive tumor samples and run three layers of analysis:
- Bulk gene expression profiling, to classify tumors into clusters based on the differential expression of molecular and gene signatures.
- Spatial whole transcriptome analysis, to look for molecular and immune signatures that predict resistance or sensitivity to first-line chemotherapy or immunotherapy.
- 9-color multiplex immunofluorescence, to map where immune cells sit inside the tumor and how they relate to each other in space.
The study also plans to compare gene expression in surgical specimens against matched treatment-naive samples from the same patients.
Beyond the tissue analysis, the study record describes a further research step: building patient-derived organoids and xenografts from tumor tissue, then using those laboratory models to test new therapeutic targets and run drug-sensitivity tests. Any new targets or actionable pathways that emerge would be validated in those models.
Why This Study Matters
The study record notes that immune checkpoint inhibitors have changed first-line treatment for these cancers, and it points to the combination of ipilimumab and nivolumab, which the record describes as approved for non-epithelioid mesothelioma in Italy. But response to immunotherapy varies widely, and mesothelioma carries a heterogeneous genomic landscape along with a tumor immune microenvironment the study describes as “altered-suppressed” or “excluded.”
Imaging-Meso is an effort to understand that variation at the molecular level. By reading the immune and genetic signatures of each tumor, the researchers want to identify which subgroups are likely to respond to which therapies. That kind of biological map is a step that comes before treatment trials, not a treatment trial itself. It is worth being precise here: this study describes tumor biology and builds laboratory models. It does not test a new drug in patients, and it does not report survival outcomes.
Who Can Participate
The study enrolls adults aged 18 and older with mesothelioma of the pleura or peritoneum. According to the eligibility criteria, key requirements include:
- A confirmed mesothelioma diagnosis of the pleura or peritoneum
- For patients undergoing surgery, both biopsy and surgical sampling material
- Pathologist confirmation that tumor sections are present in the excised specimens
- Follow-up from active cancer treatment for at least six months
People are excluded if their biological material is inadequate for the analyses, if they are not candidates for active oncologic treatment, or if they are lost to follow-up before six months after the end of active treatment.
The study is listed on ClinicalTrials.gov as NCT06581549. The central contacts on the record are Giulia Pasello, MD, and Gian Luca De Salvo, MD, both at Istituto Oncologico Veneto. People interested in participating should discuss eligibility with their oncologist and review the full criteria on the ClinicalTrials.gov listing.
Study Locations
The study record lists 10 recruiting centers across Italy:
- Istituto Oncologico Veneto, Padova
- Istituto Clinico Humanitas, Rozzano (Milano)
- Centro di Riferimento Oncologico (CRO) IRCCS, Aviano
- Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria
- ASST Papa Giovanni XXIII, Bergamo
- IRCCS Ospedale Policlinico San Martino, Genova
- ASST Grande Ospedale Metropolitano Niguarda, Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
- Azienda Ospedaliero-Universitaria di Parma, Parma
- Azienda Ospedaliera Universitaria Integrata Verona, Verona
Limitations to Consider
This is an observational study, so it does not test whether any treatment works. It is designed to generate biological insight, not survival data. The findings would need to be confirmed and then translated into treatment trials before they could change patient care.
The study is also based in Italy, and all 10 sites are Italian centers, so it is not an enrollment option for patients outside the country. The estimated primary completion date on the record is December 31, 2026, and the broader laboratory work, including the organoid and xenograft models, is expected to take longer.
References
ClinicalTrials.gov. Immune Microenvironment and Gene Expression Profiling in Mesothelioma (Imaging-Meso).
https://clinicaltrials.gov/study/NCT06581549
Istituto Oncologico Veneto. Istituto Oncologico Veneto IRCCS.
https://www.ioveneto.it/
Reader Q&A
Frequently Asked Questions
Is Imaging-Meso a drug trial?
No. Imaging-Meso (NCT06581549) is an observational study. It collects and analyzes tumor tissue using gene expression profiling, spatial transcriptomics, and multiplex immunofluorescence. No experimental drug is given to participants as part of the study. The record does mention ipilimumab and nivolumab as existing approved immunotherapy in Italy, but those are context, not interventions tested by this study.
Who is running the Imaging-Meso study?
The study is sponsored by Istituto Oncologico Veneto IRCCS in Italy, with Giulia Pasello, MD, listed as principal investigator. It is recruiting at 10 Italian centers, coordinated from Padova.
How many people will the study enroll?
The study plans to enroll 220 people with pleural or peritoneal mesothelioma, 150 retrospectively and 70 prospectively, according to the ClinicalTrials.gov record.
What does the study hope to learn?
The study aims to classify mesothelioma tumors into molecular subgroups based on their gene expression and immune microenvironment, and to find signatures that predict resistance or sensitivity to chemotherapy or immunotherapy. The longer-term goal stated in the record is to support more personalized treatment approaches, with new targets validated in patient-derived organoid and xenograft models.
Does the study report whether a treatment works?
No. As an observational profiling study, Imaging-Meso does not measure treatment efficacy or survival. Its outcomes are tumor classifications and molecular and immune signatures. Any therapeutic implications would need to be tested in separate treatment trials.