18F-Fluciclovine PET and Multiparametric MR Imaging

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate the use of the investigational agent Axumin (fluciclovine-F18) with PET/CT imaging in combination with standard MR imaging to detect remaining or recurrent brain tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University
• Collaborator: Blue Earth Diagnostics

Criteria

Inclusion Criteria:

1. Patients with prior histological confirmation of glioma or metastatic brain tumor evaluated for tumor recurrence or radiation changes after initial treatment of surgery, external beam radiation and / or chemotherapy with temozolamide.

2. Male and female

3. Ages 18 or greater

Exclusion Criteria:

1. Patient diagnosis with glioma or metastatic brain tumor but prior to surgery, external beam radiation and /or chemotherapy

2. Women who were pregnant, breast feeding, or possibly pregnant.

3. Patients with hepatic or renal dysfunction.

4. Patients with MRI contraindications (i.e. pacemakers, non-MR compatible devices).

5. Patients with a history of drug hypersensitivity to 18F-Fluciclovine.