Status:
COMPLETED
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma
Lead Sponsor:
James Mountz
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot study to assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interva...
Detailed Description
In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. All glioma cases undergoing resection at UPM...
Eligibility Criteria
Inclusion
- 1\. Age ≥ 18 years old.
- 2\. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
- 3\. Agree to use adequate contraception as indicated in this protocol.
- 4\. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.
- 5\. Able to comply with study procedures.
- 6\. Able to give written consent.
- 7\. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.
Exclusion
- 1\. Are a pregnant or breastfeeding female.
- 2\. Are participating in a clinical trial of another unlicensed product.
- 3\. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.
- 4\. Have a hypersensitivity to 18F-fluciclovine.
- 5\. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.
- 6\. Have a non-MRI compatible implantable device or another contraindication for MRI scan.
- 7\. Are deemed ineligible to participate for other reasons by an investigator.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04114370
Start Date
October 22 2019
End Date
September 30 2021
Last Update
December 6 2022
Active Locations (1)
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1
UPMC Hospitals
Pittsburgh, Pennsylvania, United States, 15213