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Response Evaluation in Malignant Pleural Mesothelioma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969098
First Posted: August 31, 2009
Last Update Posted: August 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Istituto Clinico Humanitas
  Purpose
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.

Condition
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 ]

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 ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969098


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

Publications:

Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00969098     History of Changes
Other Study ID Numbers: ONC/OSS-02/2009
First Submitted: August 6, 2009
First Posted: August 31, 2009
Last Update Posted: August 6, 2015
Last Verified: August 2015

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:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial