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.
|First Received Date||June 26, 2015|
|Last Changed Date||November 18, 2016|
|Start Date||September 2014|
|Anticipated Primary Completion Date||September 2017|
|Primary Outcome Measures||
Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis [Time Frame: Change from Baseline in SUVmax up to 1 week after talc pleurodesis.]
|Study Arms / Comparison Groups||0 / 1|
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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Egesta Lopci, MD
Phone: +39 0282247542
- 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;
|Sponsor||Istituto Clinico Humanitas|
|Verification Date||November 2016|