Finding studies
Finding studies
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Lead
Guido A. Davidzon, MD, SM
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
