Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

NCT04114370 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19010216
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 interval post chemoradiation. \[F-18\]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after \[F-18\]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.

  To assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression as compared to F-18 FDG, regions of interest will be drawn around MRI anatomically defined enhancing tumor regions and translated to both the F-18 FDG and F-18 fluciclovine PET scans to obtain SUV for each tracer. The SUV values will be correlated with the diagnosis of pseudoprogression versus tumor progression as determined by the regression of lesion enhancement on subsequent standard clinical follow up MRI imaging, as described in the protocol.

  90 minutes

Study Arms (1)

Participants with Glioma

EXPERIMENTAL

\[F18\]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.

Drug: 18F-fluciclovine

Interventions

18F-fluciclovine DRUG

Prior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration.

Participants with Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old.
• \. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.
• \. Agree to use adequate contraception as indicated in this protocol.
• \. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.
• \. Able to comply with study procedures.
• \. Able to give written consent.
• \. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.

You may not qualify if:

• \. Are a pregnant or breastfeeding female.
• \. Are participating in a clinical trial of another unlicensed product.
• \. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.
• \. Have a hypersensitivity to 18F-fluciclovine.
• \. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.
• \. Have a non-MRI compatible implantable device or another contraindication for MRI scan.
• \. Are deemed ineligible to participate for other reasons by an investigator.

Sponsors & Collaborators

• James Mountz: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

UPMC Hospitals

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.

  PMID: 34081125 DERIVED

MeSH Terms

Conditions

Glioma

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• James M Mountz, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: October 3, 2019
• Study Start: October 22, 2019
• Primary Completion: May 18, 2021
• Study Completion: September 30, 2021
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)