Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Sanjiv Sam Gambhir

Intervention(s):

  • Drug: Fluorine F 18 DASA-23
  • Procedure: Positron Emission Tomography

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hari Priya Yerraballa
650-724-9363
Recruiting