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[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

Accepts Healthy Volunteers

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

Yes
Study Type

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.

Interventional
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

Trial ID:

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.

NCT03539731
Phase

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
Lead Sponsor

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

Sanjiv Sam Gambhir
Principal Investigator

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

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

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

Other
Overall Status Recruiting
Countries United States
Conditions

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

Healthy Subject, Intracranial Neoplasm, Recurrent Glioblastoma
Additional Details

PRIMARY OBJECTIVES:

  • 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.
SECONDARY OBJECTIVES:
  • 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

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.

Stanford University, School of Medicine, Palo Alto, California

Status

Recruiting

Address

Stanford University, School of Medicine

Palo Alto, California, 94304

Site Contact

Hari Priya M. Yerraballa

yhpriya@stanford.edu

650-724-9363