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Response Evaluation in Malignant Pleural Mesothelioma

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Istituto Clinico Humanitas Identifier:
First received: August 6, 2009
Last updated: August 5, 2015
Last verified: August 2015
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.

Malignant Pleural Mesothelioma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Humanitas:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery

Inclusion Criteria:

  • 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
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Please refer to this study by its identifier: NCT00969098

Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information


Responsible Party: Istituto Clinico Humanitas Identifier: NCT00969098     History of Changes
Other Study ID Numbers: ONC/OSS-02/2009 
Study First Received: August 6, 2009
Last Updated: August 5, 2015
Health Authority: Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:
Histologically proven of Malignant pleural mesothelioma;
Patients not candidate to radical surgery;
Candidate to first-line pemetrexed-based chemotherapy;

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial processed this record on October 21, 2016