This trial is active, not recruiting.

Condition malignant pleural mesothelioma
Sponsor Istituto Clinico Humanitas
Start date June 2009
End date August 2015
Trial size 150 participants
Trial identifier NCT00969098, ONC/OSS-02/2009


Recently, a few small trials have shown promising results on value of fluoro-2-deoxy-D-glucose and positron emission tomography imaging in response assessment in Malignant Pleural Mesothelioma. These studies considered different parameters in Positron Emission Tomography (PET) analysis, mainly the standardized uptake value and volume-based parameters such as total glycolytic volume.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients.
time frame: 4 months

Secondary Outcomes

To extend the analysis to another series of consecutive patients with MALIGNANT PLEURAL MESOTHELIOMA treated with first-line pemetrexed-based chemotherapy, and to perform a combined analysis of the two groups.
time frame: 4 months
To validate the new liver-based threshold semi-automated algorithm on the GE ADW4.6 workstation with the algorithm validated in step 1 in the same subset of patients.
time frame: 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically proven MALIGNANT PLEURAL MESOTHELIOMA - Patients not candidate to radical surgery - Unidimensionally and/or bidimensionally CT-measurable disease and Candidate to first-line pemetrexed-based chemotherapy Exclusion Criteria: - Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA

Additional Information

Official title Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)
Principal investigator Armando Santoro, MD
Description This is a retrospective analysis of two consecutive and homogeneous series of Malignant Pleural Mesothelioma patients treated with first-line pemetrexed-based chemotherapy and evaluated by CT scan and FDG-PET.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Istituto Clinico Humanitas.