- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519049
11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)
Diagnostic and Prognostic Role of 11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM) and Candidate to Pleurodesis
Study Overview
Detailed Description
This is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. All patients affected by MPM and referred to our Institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. In all cases patients will be investigated with 11C-Methionine PET/CT and 18F-FDG PET/CT before talc pleurodesis, one week after and at the end of three cycles of chemotherapy.
A minimum number of 20 patients will be considered for the analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Milano
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Rozzano, Milano, Italy, 20089
- Istituto Clinico Humanitas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy.
- obtained informed consent
Exclusion Criteria:
- patients age <18 years
- pregnancy or breast-feeding;
- patients affected by other malignancies within the last 3 years;
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis
Time Frame: Change from Baseline in SUVmax up to 1 week after talc pleurodesis.
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Change from Baseline in SUVmax up to 1 week after talc pleurodesis.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Egesta Lopci, MD, Humanitas Clinical and Research Hospital
Publications and helpful links
General Publications
- Lopci E, Zucali PA, Ceresoli GL, Perrino M, Giordano L, Gianoncelli L, Lorenzi E, Gemelli M, Santoro A, Chiti A. Quantitative analyses at baseline and interim PET evaluation for response assessment and outcome definition in patients with malignant pleural mesothelioma. Eur J Nucl Med Mol Imaging. 2015 Apr;42(5):667-75. doi: 10.1007/s00259-014-2960-y. Epub 2014 Nov 18.
- 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.
- Ceresoli GL, Chiti A, Santoro A. 11C-labeled methionine and evaluation of malignant pleural mesothelioma. N Engl J Med. 2007 Nov 8;357(19):1982-4. doi: 10.1056/NEJMc071823. No abstract available.
- Lopci E, Novellis P, Testori A, Rahal D, Voulaz E, Bottoni E, Ferraroli GM, Crepaldi A, Ceresoli GL, Perrino M, Castello A, Alloisio M, Veronesi G, Zucali PA. In-vivo imaging of methionine metabolism in patients with suspected malignant pleural mesothelioma. Nucl Med Commun. 2019 Nov;40(11):1179-1186. doi: 10.1097/MNM.0000000000001078.
- Zucali PA, Lopci E, Ceresoli GL, Giordano L, Perrino M, Ciocia G, Gianoncelli L, Lorenzi E, Simonelli M, De Vincenzo F, Setti LR, Bonifacio C, Bonomi M, Bombardieri E, Chiti A, Santoro A. Prognostic and predictive role of [18 F]fluorodeoxyglucose positron emission tomography (FDG-PET) in patients with unresectable malignant pleural mesothelioma (MPM) treated with up-front pemetrexed-based chemotherapy. Cancer Med. 2017 Oct;6(10):2287-2296. doi: 10.1002/cam4.1182. Epub 2017 Sep 21.
- Bonomi M, De Filippis C, Lopci E, Gianoncelli L, Rizzardi G, Cerchiaro E, Bortolotti L, Zanello A, Ceresoli GL. Clinical staging of malignant pleural mesothelioma: current perspectives. Lung Cancer (Auckl). 2017 Aug 18;8:127-139. doi: 10.2147/LCTT.S102113. eCollection 2017.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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