Clinical Trial Finder

68Ga-citrate PET/MR Imaging for Glioma

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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.)

Trial Details

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.

Trial ID:
NCT03335280

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.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of California, San Francisco

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Michael Evans, PhD
Principal Investigator Affiliation University of California, San Francisco

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Glioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94107

Site Contact

Kenneth Gao, BS

kenneth.gao@ucsf.edu

415-353-9437

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