Clinical trial NCT02519049: 11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)
Official title: Diagnostic and Prognostic Role of 11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM) and Candidate to Pleurodesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mesothelioma, Malignant
Keywords: Mesothelioma
11C-methionine PET
talc pleurodesis
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients affected by MPM and referred to our Institution for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. A minimum number of 20 patients will be considered for the analysis.

Brief summary: Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis
timeFrame: Change from Baseline in SUVmax up to 1 week after talc pleurodesis.
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Humanitas Clinical and Research Hospital
name: Egesta Lopci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.