UnknownPhase 3

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

United States30 participantsStarted 2022-08-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Brain tumor progression

Timeframe: 20 weeks

Trial details

NCT IDNCT05479136

SponsorNicole Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Poonam Choudhary, PhD

602-406-7810 Poonam.Choudhary@barrowneuro.org

View on ClinicalTrials.gov More Grade III or Grade IV Glioma trials