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11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

Information source: Istituto Clinico Humanitas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mesothelioma, Malignant

Intervention: No intervention (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Istituto Clinico Humanitas

Official(s) and/or principal investigator(s):
Egesta Lopci, MD, Principal Investigator, Affiliation: Humanitas Clinical and Research Hospital

Overall contact:
Egesta Lopci, MD, Phone: +39 0282247542, Email: egesta.lopci@humanitas.it

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.

Clinical Details

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 design: Time Perspective: Prospective

Primary outcome: Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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;

Locations and Contacts

Egesta Lopci, MD, Phone: +39 0282247542, Email: egesta.lopci@humanitas.it

Istituto Clinico Humanitas, Rozzano, Milano 20089, Italy; Recruiting
Egesta Lopci, MD, Phone: +39 0282247542
Additional Information

Related 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. Epub 2007 Aug 30. Review.

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.

Starting date: September 2014
Last updated: August 7, 2015

Page last updated: August 23, 2015

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