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

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ClinicalTrials.gov Identifier: NCT02519049
Recruitment Status : Unknown
Verified November 2016 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment
Mesothelioma, Malignant Other: No intervention

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.


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Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: Prospective
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 Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Methionine


Intervention Details:
  • Other: No intervention
    This is an observational study


Primary Outcome Measures :
  1. 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. ]

Biospecimen Retention:   Samples Without DNA
Biopsy specimen


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:   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.
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;

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): NCT02519049


Contacts
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Contact: Egesta Lopci, MD +39 0282247542 egesta.lopci@humanitas.it
Contact: Paolo Zucali, MD +39 0282244061 paolo.zucali@humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Egesta Lopci, MD    +39 0282247542      
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Egesta Lopci, MD Humanitas Clinical and Research Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02519049     History of Changes
Other Study ID Numbers: 1287
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by Istituto Clinico Humanitas:
Mesothelioma
11C-methionine PET
talc pleurodesis
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial