Clinical trial NCT00969098: Response Evaluation in Malignant Pleural Mesothelioma
Official title: Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Mesothelioma
Keywords: Histologically proven of Malignant pleural mesothelioma;
Patients not candidate to radical surgery;
Candidate to first-line pemetrexed-based chemotherapy;
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients.
timeFrame: 4 months
Secondary outcomes:
measure: 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.
timeFrame: 4 months
measure: 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.
timeFrame: 4 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
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