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

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.

Tracking Information
First Received DateJune 26, 2015
Last Changed DateNovember 18, 2016
Start DateSeptember 2014
Anticipated Primary Completion DateSeptember 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.]

Descriptive Information
PhaseN/A
Study TypeObservational
Condition
  • Mesothelioma, Malignant
Intervention
  • Other: No intervention
Study Arms / Comparison Groups0 / 1
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 Information
Recruitment StatusRecruiting
Anticipated Enrollment20
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Egesta Lopci, MD
Email: egesta.lopci@humanitas.it
Phone: +39 0282247542
Eligibility Criteria

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;

Administrative Information
NCTIDNCT02519049
Responsible Party,
SponsorIstituto Clinico Humanitas
Verification DateNovember 2016
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