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

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.

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