- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03926507
Recruitment Status Recruiting
First Posted April 24, 2019
Last update posted November 27, 2019
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.
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.
|Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 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.
Procedure: Computed Tomography
Undergo PET/CT scan
Other: Fluciclovine F18
Procedure: Positron Emission Tomography
Undergo PET/CT scan
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- Patient is a candidate for brain tumor resection and radiation with lesion suspected
to be or previously biopsy proven to be a glioblastoma.
- Patient is able to understand and give consent to participation in the study.
- Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
- Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60
- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other
conditions that are not MR safe, which include but are not limited to:
- Electronically, magnetically, and mechanically activated implants
- Ferromagnetic or electronically operated active devices like automatic
cardioverter defibrillators and cardiac pacemakers
- Metallic splinters in the eye
- Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
- Cochlear implants
- Other pacemakers, e.g., for the carotid sinus
- Insulin pumps and nerve stimulators
- Non-MR safe lead wires
- Prosthetic heart valves (if dehiscence is suspected)
- Non-ferromagnetic stapedial implants
- Claustrophobia that does not readily respond to oral medication.
Contact: Jason M Johnson 713-792-8443 email@example.com
United States, Texas
M D Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center