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
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