11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

N/ACompletedNCT02519049

Istituto Clinico Humanitas30 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mesothelioma, Malignant

Interventions

No interventionOTHER

This is an observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy. * obtained informed consent Exclusion Criteria: * patients age \<18 years * pregnancy or breast-feeding; * patients affected by other malignancies within the last 3 years;

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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