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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
27
Given IV
Undergo PET scan
Stanford University, School of Medicine
Palo Alto, California, United States
Change in [18F]DASA-23 PET scan signal in patients with suspected recurrent glioblastoma
Response to treatment is based on the response assessment in neuro-oncology (RANO) criteria. Each patient will be dichotomized into responding (yes) or not responding (no) to treatment based on RANO criteria. The \[18F\]DASA-23 PET scan signal will be calculated according to the European Organization for Research and Treatment of Cancer (EORTC) response criteria guidelines and reported as median and range, both for the entire cohort as well as separately for the responder and non-responder subgroups. The Mann-Whitney test of \[18F\]DASA-23 PET scan signal between responders and non-responders will be performed.
Time frame: From pre-treatment to one week after initiation of treatment
Sensitivity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Sensitivity will be reported as a percentage with 95% confidence interval.
Time frame: Time of the [18F]DASA-23 PET scan
Specificity of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Specificity will be reported as a percentage with 95% confidence interval
Time frame: Time of the [18F]DASA-23 PET scan
Accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
Accuracy will be reported as a percentage with 95% confidence interval.
Time frame: Time of the [18F]DASA-23 PET scan
Progression-free survival in patients with suspected recurrent glioblastoma
The percent change in SUV from the pre-treatment \[18F\]DASA-23 PET scan to the post-treatment \[18F\]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in progression-free survival will be performed. A Cox proportional-hazards regression of progression-free survival on group will be performed. Progression-free survival will be reported as median survival time, with range.
Time frame: Time from diagnosis up to 1 year
Overall survival in patients with suspected recurrent glioblastoma
The percent change in SUV from the pre-treatment \[18F\]DASA-23 PET scan to the post-treatment \[18F\]DASA23 PET scan will be calculated. Patients will be divided into two groups based on whether their percent change in SUV is above or below the median. Kaplan-Meier curves for the two groups will be plotted and a log-rank test for difference in overall survival will be performed. A Cox proportional-hazards regression of overall survival on group will be performed. Overall survival will be reported as median survival time, with range.
Time frame: From time of initial diagnosis up to 2 years
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