Response Evaluation in Malignant Pleural Mesothelioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was Active, not recruiting
Information provided by:
Istituto Clinico Humanitas
First received: August 6, 2009
Last updated: September 1, 2010
Last verified: September 2010
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
||Observational Model: Cohort
Time Perspective: Retrospective
||Early Response Evaluation in Malignant Pleural Mesothelioma By Total Glycolytic Volume (TGV) Analysis of Serial FDG-PET Scans (Positron Emission Tomography Scans)
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Histologically proven MALIGNANT PLEURAL MESOTHELIOMA and Patients not candidate to radical surgery
- 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
- Histologically not proven MALIGNANT PLEURAL MESOTHELIOMA
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00969098
|Istituto Clinico Humanitas
|Rozzano, Milano, Italy, 20089 |
Istituto Clinico Humanitas
||Armando Santoro, MD
||Istituto Clinico Humanitas
No publications provided
||Armando Santoro, MD, Istituto Clinico Humanitas
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 6, 2009
||September 1, 2010
||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:
ClinicalTrials.gov processed this record on July 31, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type