Status:
UNKNOWN
Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Collaborating Sponsors:
Barrow Neurological Foundation
Arizona Biomedical Research Commission (ABRC)
Conditions:
Newly Diagnosed Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the this study is to see if the use of a PET scan with 18F-fluciclovine (PET or Fluciclovine PET) in addition to the normal radiation planning imaging procedures (MRI and CT scan) will ...
Detailed Description
The goal of this study is to see if the use of PET in planning radiotherapy can reduce these local failures. Glioblastoma (GBM) is the most common primary malignant brain tumor. Newly diagnosed gliob...
Eligibility Criteria
Inclusion
- Histological diagnosis of primary, newly diagnosed supratentorial, WHO grade IV glioma
- Greater than 18 years of age
- Karnofsky performance score greater than 70%
- Recovered from surgery and on a stable or tapering dose of corticosteroids
- Plan to undergo standard therapy with XRT 60Gy/30fx with TMZ followed by 6-12 cycles of maintenance TMZ within 6 weeks of surgery
- If woman of child bearing potential, negative serum pregnancy test. Patients must agree to take adequate pregnancy preventions for the length of the study.
- Life expectancy of at least 3 months
- Written study specific consent
Exclusion
- Previous treatment of glioma of any grade with bevacizumab or other molecular targeted therapies less than 6 months before MRI (and PET) used for radiotherapy planning
- Recurrent of multifocal malignant glioma
- Any sites of distant disease (for example drop metastases or leptomeningeal spread)
- Prior use of Gliadel wafers or any other intratumal or intracavity treatment
- Prior radiotherapy to the cranium, head and neck or other sites resulting in overlapping fields
- Molecular targeted therapies planned during radiotherapy
- Simultaneous participation in other interventional trials which could interfere with this trial or participation in a clinical trial within the last thirty days before patient's enrollment in current study.
- Inability to undergo an MRI or PET (Claustrophobia, non-MRI compatible pacemaker, known allergy to MRI contrast agent or fluciclovine tracer)
- Any pregnant or lactating patient
- Any prior malignancy within 3 years excluding carcinoma in-situ or early staged,localized basal or squamous cell skin cancers
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04840069
Start Date
June 7 2021
End Date
March 30 2024
Last Update
January 13 2023
Active Locations (1)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013