11C-Methionine PET as Prognostic Marker of Gliomas
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Istituto Clinico Humanitas|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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Istituto Clinico Humanitas
Rozzano, Milano, 20089
Egesta Lopci, MD