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

Sponsor
Nicole Hill (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05479136
Collaborator
Blue Earth Diagnostics (Industry), Barrow Neurological Foundation (Other)
30
1
16

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: PET imaging with 18F fluciclovine
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Up to 30 eligible patients will be recruited from out-patient clinic visits at Barrow Neurological Institute.Up to 30 eligible patients will be recruited from out-patient clinic visits at Barrow Neurological Institute.
Masking:
None (Open Label)
Masking Description:
All participants will receive the same imaging.
Primary Purpose:
Other
Official Title:
18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Brain tumor progression [20 weeks]

      whether fluciclovine PET, a commercially available tracer, provides A reliable measure of brain tumor progression months earlier than conventional MRI.

    Secondary Outcome Measures

    1. PET uptake and dynamic susceptibility contrast (DSC) perfusion [20 weeks]

      Establish the spatial correlation between PET uptake and dynamic susceptibility contrast (DSC) perfusion MRI measurements of relative cerebral blood volume (rCBV).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nicole Hill
    • Blue Earth Diagnostics
    • Barrow Neurological Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicole Hill, Program Manager, St. Joseph's Hospital and Medical Center, Phoenix
    ClinicalTrials.gov Identifier:
    NCT05479136
    Other Study ID Numbers:
    • PHX-22-500-229-30-08
    • BED-IIT-420
    First Posted:
    Jul 29, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2022