18F-Fluciclovine PET Imaging for Detecting High Grade Glioma Recurrence After Radiochemotherapy
DRARCH
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedStudy Start
First participant enrolled
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 27, 2022
October 1, 2022
1.4 years
June 24, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
PET uptake and dynamic susceptibility contrast (DSC) perfusion
20 weeks
Study Arms (1)
PET study
EXPERIMENTALSingle intravenous administration of 18F fluciclovine for PET Scan
Interventions
PET with 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Eligibility Criteria
You may qualify if:
- Greater than 18 years of age
- Histological diagnosis of primary WHO grade III or IV glioma
- Completed standard radiotherapy
- Undergoing or completed standard chemotherapy (or other therapies)
- Enlarging or new contrast-enhancing mass suspicious for progression/recurrence (at least 10mm in one direction)
- Subjects must agree to take adequate pregnancy preventions from the time of consent until 24 hrs after the 18F-fluciclovine injection.
- 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
You may not qualify if:
- Simultaneous participation in other interventional trials which could interfere with this trial.
- Inability to undergo a MRI or PET scan (claustrophobia, non-MRI compatible pacemaker, renal insufficiency, known allergy to MRI contrast agent or fluciclovine tracer)
- Subjects who are pregnant or lactating or who suspect they might be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nicole Hilllead
- Blue Earth Diagnosticscollaborator
- Barrow Neurological Foundationcollaborator
Study Sites (1)
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Poonam Choudhary, PhD
Barrow Neurological Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All participants will receive the same imaging.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Program Manager
Study Record Dates
First Submitted
June 24, 2022
First Posted
July 29, 2022
Study Start
August 24, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share