Primary Outcome Measures Overall Survival Secondary Outcome Measures Progression Free Survival Best Response: Objective Response Rate (ORR) Best Response: Disease Control Rate (DCR) Best Response: Clinical Benefit Rate (CBR) Other Outcome Measures Survival Rate at 12 Months Survival Rate at 18 Months Survival Rate at 24 Months Survival Rate at[…]
Clinical Trials
First Local Anaesthesia Thoracoscopy for Pleural Effusion Diagnosis. (FLAT)
Primary Outcome Measures Time to Diagnosis Hospitalization time Secondary Outcome Measures Patient’s discomfort/pain Complications Rate of Non Specific Pleuritis Inclusion Criteria Undiagnosed pleural effusion with the character of a lymphocytic exudate Exclusion Criteria Empyema Transudate pleural effusion. Central airway obstruction by tumor. Existence of extensive adhesions that do not allow[…]
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Primary Outcome Measures Number of Patients who Experience Dose-Limiting Toxicity Number of patients who experience a treatment-related adverse event Objective response rate (ORR) Duration of response (DOR) Progression free survival (PFS) Overall survival (OS) Secondary Outcome Measures Area under the plasma concentration versus time curve (AUC) Time to achieve maximal[…]
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.
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[…]
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[…]
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[…]
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[…]
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[…]
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).
