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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Glioblastoma

Treatments: Other: Fluciclovine F18; Procedure: Computed Tomography; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03926507

2018-0869 (Other Identifier)

NCI-2019-01532 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Diagnostic (fluciclovine F18 PET/CT)

Experimental group

Description:

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.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Other: Fluciclovine F18