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

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.

Study Overview

• Status: Recruiting
• Conditions: Grade III or Grade IV Glioma
• Intervention / Treatment: Drug: PET imaging with 18F fluciclovine

Detailed Description

Approximately 40-50% of all glioblastoma patients undergoing standard of care radiochemotherapy will show signs of early disease progression that includes increases in the apparent tumor size on conventional magnetic resonance imaging (MRI) scans. Unfortunately, treatment related effects, including alterations to the blood brain barrier (BBB), can mimic tumor progression on conventional MRI scans, which confounds assessment of tumor progression during and in the months following radiochemotherapy.

An imaging method that provides a reliable early assessment of brain tumor progression could enable patients to enroll into clinical trials months earlier (when tumors are more treatable) and potentially save patients from the adverse side effects of an ineffective radiochemotherapy regimen. Fluciclovine positron emission tomography (PET) imaging has the potential to overcome the limitations of conventional MRI and provide an earlier, more comprehensive assessment of brain tumor progression. Fluciclovine is a radiolabeled amino acid analogue whose transport across the BBB and retention in tumor cells is dictated primarily by upregulated amino acid transporters. Prior studies have shown that amino acid PET with radiotracers similar to fluciclovine can accurately distinguish tumor progression from treatment effects in glioma patients, but these other amino acid radiotracers are not widely available. Another advantage of fluciclovine PET is that is can detect infiltrative tumor cells that are often not discernable on standard conventional MRI and are often in regions beyond that those with disrupted BBB. There are no published studies evaluating whether fluciclovine PET can differentiate progression from treatment effects despite fluciclovine being commercially available and widely accessible. The goals of this proposal are to establish whether fluciclovine PET can: i) identify early progression at time points soon after completion of radiation therapy and ii) differentiate treatment-related effects from true disease progression in patients with suspected recurrent disease.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Poonam Choudhary, PhD; Phone Number: 602-406-7810; Email: Poonam.Choudhary@barrowneuro.org
• Study Contact Backup: Name: John Karis, MD; Phone Number: 602-406-4089; Email: jkaris@barrowneuro.org

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
      • Contact: Poonam Choudhary; Phone Number: 602-406-7810; Email: Poonam.Choudhary@barrowneuro.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET study; Single intravenous administration of 18F fluciclovine for PET Scan	Drug: PET imaging with 18F fluciclovine; PET with 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus; Other Names: Axumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain tumor progression	whether fluciclovine PET, a commercially available tracer, provides A reliable measure of brain tumor progression months earlier than conventional MRI.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET uptake and dynamic susceptibility contrast (DSC) perfusion	Establish the spatial correlation between PET uptake and dynamic susceptibility contrast (DSC) perfusion MRI measurements of relative cerebral blood volume (rCBV).	20 weeks

Collaborators and Investigators

• Sponsor: Nicole Hill
• Collaborators: Blue Earth Diagnostics; Barrow Neurological Foundation
• Investigators: Principal Investigator: Poonam Choudhary, PhD, Barrow Neurological Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Recurrence; Glioma
• Other Study ID Numbers: PHX-22-500-229-30-08; BED-IIT-420 (Other Identifier: Blue Earth Diagnostics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes