F18 Fluciclovine PET / CT in Assessing Tumor Volume and Radiation Therapy Response in Patients with Glioblastoma Undergoing Surgery

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Pregnant.
  • Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
  • Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m^2.
  • 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 * Pregnancy * Claustrophobia that does not readily respond to oral medication.

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Jason Michael Johnson
Phone: 713-792-8443

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Jason Michael Johnson

Trial IDs

Primary ID 2018-0869
Secondary IDs NCI-2019-01532
Clinicaltrials.gov ID NCT03926507