11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)
- Conditions
- Mesothelioma, Malignant
- Registration Number
- NCT02519049
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.
- Detailed Description
This is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. All patients affected by MPM and referred to our Institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. In all cases patients will be investigated with 11C-Methionine PET/CT and 18F-FDG PET/CT before talc pleurodesis, one week after and at the end of three cycles of chemotherapy.
A minimum number of 20 patients will be considered for the analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy.
- obtained informed consent
- patients age <18 years
- pregnancy or breast-feeding;
- patients affected by other malignancies within the last 3 years;
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis Change from Baseline in SUVmax up to 1 week after talc pleurodesis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy