18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT03732352
- Phase
- PHASE2
- Status
- Completed
Conditions
- EGFR Gene Amplification
- EGFR Gene Mutation
- Glioblastoma
- Recurrent Glioblastoma
- Supratentorial Glioblastoma
- TP53 Wt Allele
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fludeoxyglucose F-18 — OTHERGiven IV
- Osimertinib — DRUGGiven PO
- Positron Emission Tomography — PROCEDUREUndergo fludeoxyglucose F-18 PET scan
Study Details
This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and osimertinib works in evaluating glucose utilization in patients with EGFR activated glioblastoma. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 18F-FDG PET imaging may help to detect changes in tumor glucose utilization, which may allow investigators to obtain an early read out on the impact of osimertinib on recurrent glioblastoma patients whose tumors have EGFR activation.
Key Dates
- Start date
- Nov 28, 2018
- Status verified
- Nov 2024
- Primary completion
- Jan 31, 2024
- Completion
- Jan 31, 2024
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (18F-FDG PET, osimertinib)Within days -28 to -4, patients receive fludeoxyglucose F-18 IV and after 60 minutes undergo PET scan over 15 minutes. After 18-54 hours, patients undergo a second fludeoxyglucose F-18 PET scan. Patients then receive osimertinib PO QD on days -3 to -1 and after 24-72 hours, undergo a third fludeoxyglucose F-18 PET scan. Patients then receive osimertinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Intrapatient variance of tumor fludeoxyglucose F-18 (FDG) uptake as determined by a double baseline FDG positron emission tomography (PET) prior to osimertinib exposure [ Time Frame: At baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | - |
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