Recruiting
Phase 3

18F-Fluciclovine

Sponsor:

Nicole Hill

Code:

NCT05479136

Conditions

Grade III or Grade IV Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET imaging with 18F fluciclovine

Study Details

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.

Conditions

Grade III or Grade IV Glioma

Study ID

NCT05479136

Start date

Aug 24, 2022

Status verified date

Oct, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: PET study

Single intravenous administration of 18F fluciclovine for PET Scan

Interventions

PET imaging with 18F fluciclovine

PET with 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Primary outcome measure

  • Brain tumor progression [ Time Frame: 20 weeks ]

Central Contacts and Locations

Locations

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

More Information

Sponsor

Nicole Hill

Last update posted

Oct 27, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nicole Hill on 2022-10-27.