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Response Evaluation in Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT00969098
Recruitment Status : Unknown
Verified August 2015 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2009
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease
Malignant Pleural Mesothelioma

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.

Study Type : Observational
Estimated Enrollment : 150 participants
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)
Study Start Date : June 2009
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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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

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

Publications:

Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00969098     History of Changes
Other Study ID Numbers: ONC/OSS-02/2009
First Posted: August 31, 2009    Key Record Dates
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