Clinical trial · Interventional
[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers
A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study did not meet its objectives due to difficulties in enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Healthy Subject | — | UNRESOLVED | — |
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine F 18 DASA-23 | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Group I ([18F]DASA-23, PET)
- description
- Healthy volunteers receive \[18F\]DASA-23 IV and undergo brain PET scan over 15 minutes and 4 vertex-to-toe PET scans over 30 minutes each.
- interventionNames
- Drug: Fluorine F 18 DASA-23
- Procedure: Positron Emission Tomography
- type
- EXPERIMENTAL
- label
- Group II ([18F]DASA-23, PET)
- description
- 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.
- interventionNames
- Drug: Fluorine F 18 DASA-23
- Procedure: Positron Emission Tomography
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDBeinat C, Patel CB, Haywood T, Shen B, Naya L, Gandhi H, Holley D, Khalighi M, Iagaru A, Davidzon G, Gambhir SS. Human biodistribution and radiation dosimetry of [18F]DASA-23, a PET probe targeting pyruvate kinase M2. Eur J Nucl Med Mol Imaging. 2020 Aug;47(9):2123-2130. doi: 10.1007/s00259-020-04687-0. Epub 2020 Jan 15. PMID 31938892
- DERIVEDBeinat C, Patel CB, Xie Y, Gambhir SS. Evaluation of Glycolytic Response to Multiple Classes of Anti-glioblastoma Drugs by Noninvasive Measurement of Pyruvate Kinase M2 Using [18F]DASA-23. Mol Imaging Biol. 2020 Feb;22(1):124-133. doi: 10.1007/s11307-019-01353-2. PMID 30989436