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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
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00969098
First received: August 6, 2009
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (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

Ages Eligible for Study:   18 Years and older
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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00969098     History of Changes
Other Study ID Numbers: ONC/OSS-02/2009
Study First Received: August 6, 2009
Last Updated: September 1, 2010
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:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on May 21, 2013