18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine whether positron emission tomography (PET) imaging with fluciclovine can reliably differentiate true progression from pseudoprogression months earlier than the conventional MRI methods.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicole Hill
• Collaborators: Barrow Neurological Foundation; Blue Earth Diagnostics

Criteria

Inclusion Criteria:

1. Greater than 18 years of age

2. Histological diagnosis of primary WHO grade III or IV glioma

3. Completed standard radiotherapy

4. Undergoing or completed standard chemotherapy (or other therapies)

5. Enlarging or new contrast-enhancing mass suspicious for progression/recurrence (at least 10mm in one direction)

6. Subjects must agree to take adequate pregnancy preventions from the time of consent until 24 hrs after the 18F-fluciclovine injection.

7. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative

Exclusion Criteria:

1. Simultaneous participation in other interventional trials which could interfere with this trial.

2. Inability to undergo a MRI or PET scan (claustrophobia, non-MRI compatible pacemaker, renal insufficiency, known allergy to MRI contrast agent or fluciclovine tracer)

3. Subjects who are pregnant or lactating or who suspect they might be pregnant.