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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Istituto Clinico Humanitas

Study Description

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 Design

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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

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

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Principal Investigator:	Armando Santoro, MD	Istituto Clinico Humanitas

More Information

Publications:

Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.

Sugarbaker DJ, Flores RM, Jaklitsch MT, Richards WG, Strauss GM, Corson JM, DeCamp MM Jr, Swanson SJ, Bueno R, Lukanich JM, Baldini EH, Mentzer SJ. Resection margins, extrapleural nodal status, and cell type determine postoperative long-term survival in trimodality therapy of malignant pleural mesothelioma: results in 183 patients. J Thorac Cardiovasc Surg. 1999 Jan;117(1):54-63; discussion 63-5. doi: 10.1016/s0022-5223(99)70469-1.

Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.

Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.

Ceresoli GL, Chiti A, Zucali PA, Cappuzzo F, De Vincenzo F, Cavina R, Rodari M, Poretti D, Lutman FR, Santoro A. Assessment of tumor response in malignant pleural mesothelioma. Cancer Treat Rev. 2007 Oct;33(6):533-41. doi: 10.1016/j.ctrv.2007.07.012. Epub 2007 Aug 30.

Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol. 2004 Feb;15(2):257-60. doi: 10.1093/annonc/mdh059.

Flores RM, Akhurst T, Gonen M, Zakowski M, Dycoco J, Larson SM, Rusch VW. Positron emission tomography predicts survival in malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2006 Oct;132(4):763-8. doi: 10.1016/j.jtcvs.2006.03.068.

Flores RM, Akhurst T, Gonen M, Larson SM, Rusch VW. Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2003 Jul;126(1):11-6. doi: 10.1016/s0022-5223(03)00207-1.

Weber WA. Use of PET for monitoring cancer therapy and for predicting outcome. J Nucl Med. 2005 Jun;46(6):983-95.

Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. doi: 10.1200/JCO.2006.06.8999.

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Responsible Party:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00969098
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:

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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial	Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases

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