[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracrani… (NCT03539731) | Clinical Trial Compass
TerminatedPhase 1
[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
Stopped: study did not meet its objectives due to difficulties in enrollment
United States27 participantsStarted 2018-04-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ANC ≥ 1.5 X 10\^9/L w/o myeloid growth factor support for 7 d preceding lab assessment
✓. 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
✓. Platelet count ≥ 100 X 10\^9/L w/o blood transfusions for 7 d preceding lab assessment
✓. Bilirubin ≤ 1.5 X ULN except for pts w/ documented history of Gilbert's disease
✓. ALT and AST ≤ 2.5 X ULN
✓. Alkaline phosphatase (AP) ≤ 3 X ULN
✓. Women of childbearing potential (WCBP): negative serum pregnancy test
Exclusion criteria
✕. Known allergy to adhesive tapes or other skin adhesives used in medical care
✕. Subjects with the following co-morbid disease or incurrent illness:
✕
What they're measuring
1
Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma
Timeframe: From pre-treatment to one week after initiation of treatment