68Ga-citrate PET/MR Imaging for Glioma
This is a prospective, Phase 2, single center, open-label study in adult patients with presumed WHO grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate PET/MR prior to surgery.
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 - 85 Years|
Inclusion Criteria:- WHO grade 3 or 4 glioma planning to undergo surgery - Age >= 18 years - Karnofsky performance status of >= 60 - Ability to understand a written informed consent document, and the willingness to sign it Cohort A - 20 subjects - Positive for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy Cohort B - 20 subjects - Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy
Exclusion Criteria:- Contraindications to PET imaging (e.g. pregnant or breast-feeding woman) - Contraindications to MR imaging (e.g. pacemakers, metallic implants, etc.)
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.
|University of California, San Francisco|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Contact a Trial Team
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