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11C-Methionine PET as Prognostic Marker of Gliomas

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ClinicalTrials.gov Identifier: NCT02518061
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 145 patients with glioma treated with surgery with radical intent at our center.

Condition or disease Intervention/treatment
Glioma Other: No intervention

Detailed Description:

This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 145 patients with glioma treated with surgery with radical intent at our center.

We will review 11C-Methionine PET data acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to IDH1 mutation status, MGMT promoter methylation and 1p/19q co-deletion. These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.


Study Design

Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of 11C-Methionine PET for the Prognostic and Molecular Characterization of Gliomas Candidate to Surgery.
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Other: No intervention
    This is a retrospective study

Outcome Measures

Primary Outcome Measures :
  1. Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with glioma undergoing surgery with IDH1 mutation, MGMT promoter methylation and 1p/19q co-deletion, [ Time Frame: Baseline SUVmax up to 1 month before surgery. ]

Biospecimen Retention:   Samples Without DNA
Tumor surgical specimen

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit a maximum number of 145 patients with glioma operated in our institution during 2011-2015, of which are available clinical and instrumental data and surgical tumor specimen.
Criteria

Inclusion Criteria:

  • Diagnosis of glioma
  • 11C-Methionine within 30 days before surgery

Exclusion Criteria:

  • Absence of tumor specimen
  • No clinical data
  • 11C-Methionine can not be evaluated
Contacts and Locations

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): NCT02518061


Contacts
Contact: Egesta Lopci, MD +39 0282247542 egesta.lopci@humanitas.it
Contact: Lorenzo Bello, Prof. +39 0282244640 lorenzo.bello@humanitas.it

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02518061     History of Changes
Other Study ID Numbers: 1418
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Istituto Clinico Humanitas:
Glioma; 11C-Methionine PET

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue