Clinical Trials

Hemithoracic Arc Radiotherapy Post Pleural Decortication

Primary Outcome Measures Acute Radiation Toxicity late radiation toxicity Inclusion Criteria Evidence of metastatic disease. Underwent Pleural decortication. Able to provide informed consent. Exclusion Criteria Poor pulmonary function tests. Recurrent or palliative cases. Inability to attend full course of Radiotherapy or follow up visits.

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The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)

Primary Outcome Measures Diagnostic Performance Secondary Outcome Measures Location biopsy Staging Patient Management Uptake Values Changes uptake parameters due to anticancer treatment Correlate immunohistochemistry Incidental findings Safety Evaluation FAPI-injection Overall survival Recurrence/Progression Free Survival Response evaluation Interobserver reliability Inclusion Criteria Patients with pleural lesions suspicious of pleural mesothelioma and referred[…]

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Genetic Susceptibility in MAlignant Pleural Mesothelioma: Clinical Implication of GermliNE VariaTionS (MAGNETS)

Primary Outcome Measures the comparison of prevalence of germline mutations in MPM patients vs asbestos exposed healthy subjects Secondary Outcome Measures Secondary aim will be the comparison of overall survival (OS) according to mutational status in MPM patients. Inclusion Criteria Inclusion Criteria Cohort A: Patient with a documented diagnosis of[…]

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Evaluating Ivonescimab As a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy (Bi-MAPS)

Primary Outcome Measures The analysis of the primary efficacy endpoint will be conducted in all eligible patients, based on the disease control rate (DCR) at 12 weeks according to mRECIST 1.1 for mesothelioma, which was defined as the proportion of patients with compete response (CR), partial response (PR) or stable[…]

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The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)

Primary Outcome Measures The diagnostic performance (sensitivity, specificity, positive predicative value, negative predicative value, and overall diagnostic accuracy – all parameters in %). in of FAPI PET compared to routine imaging modalities, including FDG PET/CT, in suspected PM lesions. Secondary Outcome Measures Calculate the proportion of patients where the location[…]

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The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma (FAPI-PM)

Primary Outcome Measures Calculate the proportion of patients where the location of the intended pleural biopsy is altered due to FAPI PET/CT replacing FDG PET/CT. Secondary Outcome Measures Compare the cancer stage (IASCL 9th edition TNM-classification) as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary[…]

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Study of ISM6331 in Participants With Advanced/​Metastatic Malignant Mesothelioma or Other Solid Tumors

This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).

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New Preclinical and Clinical Approaches to Mesothelioma

This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli – IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4’s role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.

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Ga-68 FAPI PET Before Immunotherapy (FAPBI)

It is aimed to evaluate FAP expression and its success in predicting treatment response before immunotherapy used in the treatment of malignant mesothelioma with Ga68 FAPI PET/CT imaging, which allows in vivo evaluation of FAP expression, which is thought to be associated with immunosuppression and resistance to immunotherapy.

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