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:

Guido A. Davidzon, MD, SM

Intervention(s):

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

Phase:

Phase 1

Eligibility


Inclusion Criteria:

Age ≥18 years old.

2. Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and
Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by:

   1. ANC ≥ 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment

   2. 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

   3. Platelet count ≥ 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment

   4. Bilirubin ≤ 1.5 X ULN except for pts w/ documented history of Gilbert's disease

   5. ALT and AST ≤ 2.5 X ULN

   6. Alkaline phosphatase (AP) ≤ 3 X ULN

   7. Women of childbearing potential (WCBP): negative serum pregnancy test

   3. Ability to stand up and climb two steps with minimal assistance.

   4. Ability to understand and the willingness to sign a written informed consent
   document.

   5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological
   evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection,
   or (b) Radiographical or pathological evidence of progressive/recurrent intracranial
   tumor, (c) Question of pseudoprogression vs. true progression on most recent
   standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain
   MRI scan of intracranial metastasis/metastases in a patient with known extracranial
   primary cancer.

   6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing
   lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM,
   molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline
   gliomas, gliosarcomas, or any other WHO Grade IV glioma) on a standard-of-care (SOC)
   brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either
   newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse
   astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or
   any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at
   least 1cm3 in size on the post-operative scan.

   7. (Part 3, GBM patients ONLY) Life expectancy of ≥ 6 months.

Exclusion Criteria:

   1. Known allergy to adhesive tapes or other skin adhesives used in medical care

   2. Subjects with the following co-morbid disease or incurrent illness:

      1. With known cirrhosis diagnosed with Child-Pugh Class A or higher liver disease.

      2. Severe/uncontrolled inter-current illness within the previous 28 days prior to
      PET scan

      3. Patients who have implantable devices that are contra-indicated for MRI

      4. Bleeding disorder

      5. Any other significant co-morbid conditions that in the opinion of the
      Investigator would impair study participation or cooperation.

      6. (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy

      7. (Healthy volunteers ONLY - Part 1 and Part 4) known kidney disease

   3. Pregnant or nursing participants

   4. History of allergic reactions to gadolinium-based MRI contrast agent

   5. (Part 2, intracranial tumor patients ONLY) Other chemotherapy (besides what is being
   used to treat the intracranial tumor)

   6. (Part 3, GBM patients ONLY) Has already begun therapy, prior to the first of two
   [18F]DASA-23 PET/MRI scans.

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
Lewis Naya
650-725-0739
Recruiting