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Response Evaluation in Malignant Pleural Mesothelioma

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.

Tracking Information
First Received DateAugust 6, 2009
Last Changed DateAugust 5, 2015
Start DateJune 2009
Actual Primary Completion DateAugust 2015
Primary Outcome Measures

To validate a semi-automated iterative threshold-based region growing algorithm in a previously published series of patients. [Time Frame: 4 months]

Secondary Outcome Measures

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]

Descriptive Information
PhaseN/A
Study TypeObservational
Condition
  • Malignant Pleural Mesothelioma
Study Arms / Comparison Groups0 / 1
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.

Recruitment Information
Recruitment StatusActive, not recruiting
Anticipated Enrollment150
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT00969098
Responsible Party,
SponsorIstituto Clinico Humanitas
Verification DateAugust 2015
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

Yes   No

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