NCT03539731

[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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Guido A. Davidzon, MD, SM · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 4 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: Subjects with glioblastoma will receive \[18F\]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes. 15-minute vertex-to-thigh PET for Part 3 patients, Participants undergo second PET scan 7 days after the initiation of therapy. GROUP IV: Healthy volunteers will undergo the same procedures as the healthy volunteers in Group I with the following exceptions: Group IV healthy volunteers will undergo a 60-minute PET/MRI brain scan instead of a 15-minute PET/MRI brain scan. Group IV healthy volunteers will not undergo any vertex-to-toe PET scans. After completion of study treatment, intracranial tumor and recurrent glioblastoma participants are followed up every 3 months for 12 months.

Conditions

• Healthy Subject
• Intracranial Neoplasm
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Fluorine F 18 DASA-23	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET scan

Timeline

• Start date: 2018-04-23
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-05-29
• Last updated: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study