[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers

Study Purpose

This phase I trial studies how well [18F]DASA-23 and positron emission tomography (PET) scan work in evaluating pyruvate kinase M2 (PKM2) expression in patients with intracranial tumors or recurrent glioblastoma and healthy volunteers. PKM2 regulates brain tumor metabolism, a key factor in glioblastoma growth. [18F]DASA-23 is a radioactive substance with the ability to monitor PKM2 activity. A PET scan is a procedure in which a small amount of a radioactive substance, such as [18F]DASA-23, is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the substance is used. Tumor cells usually pick up more of these radioactive substances, allowing them to be found. Giving [18F]DASA-23 with a PET scan may help doctors evaluate PKM2 expression in healthy volunteers and in participants with intracranial tumors or recurrent glioblastoma.

Recruitment Criteria

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

Accepts Healthy Volunteers

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
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Absolute neutrophil count (ANC) >= 1.5 X 10^9/L without (w/o) myeloid growth factor support for 7 days preceding lab assessment, obtained within 14 days prior to PET scan - Hemoglobin (Hgb) >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan, obtained within 14 days prior to PET scan - Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan - Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert?s disease, obtained within 14 days prior to PET scan - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN, obtained within 14 days prior to PET scan - Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan - Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within 14 days prior to PET scan - Karnofsky performance status (KPS) >= 60 (Parts 2 [intracranial tumor patients] and 3 [recurrent glioblastoma (GBM) patients] ONLY) - Ability to understand and the willingness to sign a written informed consent document - (Part 2, intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor - (Part 3, suspected recurrent GBM patients ONLY): Any patient with histopathologically proven GBM who, on a standard of care surveillance brain magnetic resonance imaging (MRI), has an imaging change suspicious for GBM recurrence, and whose treatment plan for the recurrence does not include surgery - (Part 3, suspected recurrent GBM patients ONLY): Life expectancy of >= 6 months

Exclusion Criteria:

- Known allergy to adhesive tapes or other skin adhesives used in medical care - Known cirrhosis diagnosed with Child Pugh class A or higher liver disease - Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan - Patients who have implantable devices that are contraindicated for MRI - Bleeding disorder - Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation - EXCLUSION - HEALTHY VOLUNTEERS: Prior or current malignancy - EXCLUSION - HEALTHY VOLUNTEERS: Known kidney disease - Pregnant or nursing participants - History of allergic reactions to gadolinium-based MRI contrast agent - (Part 2, intracranial tumor patients ONLY): Other chemotherapy (besides what is being used to treat the intracranial tumor) - (Part 3, suspected recurrent GBM patients ONLY): Has already begun non surgical therapy for any recurrence, prior to the first [18F]DASA 23 PET/MRI scan

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:

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 1

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

Lead Sponsor
Sanjiv Sam Gambhir

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

Principal Investigator
Sanjiv Gambhir
Principal Investigator Affiliation Stanford Cancer Institute Palo Alto

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

Agency Class
Overall Status Recruiting
Countries United States

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

Healthy Subject, Intracranial Neoplasm, Recurrent Glioblastoma
Additional Details


  • I. Determine whether the fluorine F 18 DASA-23 ([18F]DASA 23) PET scan signal change from pre-therapy to one week after initiation of therapy can predict the tumor's responsiveness to therapy and 6 month progression free survival (PFS6), in suspected recurrent glioblastoma.
  • I. Determine the sensitivity, specificity, and accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
  • II. Determine whether the [18F]DASA-23 PET scan signal change from pre therapy to one week after initiation of therapy can predict progression free survival (PFS) and overall survival (OS), in suspected recurrent glioblastoma.
OUTLINE: Participants are assigned to 1 of 3 groups. GROUP I: Healthy volunteers receive [18F]DASA-23 intravenously (IV) and undergo brain PET scan over 15 minutes and 4 vertex-to-toe PET scans over 30 minutes each. GROUP II: Intracranial tumor participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. GROUP III: Recurrent glioblastoma participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. Participants undergo second PET scan 7 days after the initiation of therapy. After completion of study treatment, intracranial tumor and recurrent glioblastoma participants are followed up every 3 months for 12 months.

Contact a Trial Team

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Stanford University, School of Medicine, Palo Alto, California




Stanford University, School of Medicine

Palo Alto, California, 94304

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Hari Priya M. Yerraballa



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