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Brief Title: F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
Official Title: Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
Study ID: NCT03926507
Brief Summary: This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.
Detailed Description: PRIMARY OBJECTIVES: I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging. SECONDARY OBJECTIVES: I. To assess changes in F18 fluciclovine defined disease with surgery and radiation. II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity. EXPLORATORY OBJECTIVES: I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging. OUTLINE: Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy. After completion of study, patients will be followed up at 3 and 6 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Jason M Johnson
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR