Skip to content

Clinical trial to evaluate the usefulness of fluciclovine PET in malignant brain tumors

Phase II study to evaluate the efficacy of fluciclovine PET for malignant brain tumors

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1061240127
Enrollment
30
Registered
2025-02-26
Start date
2025-06-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade glioma, Metastatic brain tumor, Primary Central Nerve System Lymphoma

Interventions

One vial of fluciclovine injection is administered intravenously, and imaging is started 10 to 50 minutes later using positron emission tomography. Imaging is performed up to 60 minutes after administ

Sponsors

Tanaka Shota
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18 years old or older 2) Patients suspected of having a malignant brain tumor based on MRI examination, and whose differential diagnosis includes malignant glioma, including glioblastoma 3) No restrictions on previous cancer history 4) Patients who have given written consent of their own free will (or a substitute decision-maker if aphasia or other condition makes it difficult for the patient to sign) after being fully informed of the study and fully understanding it

Exclusion criteria

Exclusion criteria: 1) Patients with tumorous lesions that show marked midline deviation 2) Patients with tumorous lesions presenting with severe hydrocephalus 3) Patients with a KPS score of 50 or less 4) Patients who are judged to be unable to safely undergo the examination due to severe aphasia or higher brain dysfunction 5) Patients who are judged to be unsuitable as research subjects by the principal investigator or subinvestigatorse for inclusion in the study by the principal investigator or sub-investigators.

Design outcomes

Primary

MeasureTime frame
The correlation between the quantitative evaluation of flucyclovine accumulation in flucyclovine PET and histological findings will be investigated. The quantitative evaluation of flucyclovine will be obtained and evaluated as a standardized uptake value (SUV) value.

Secondary

MeasureTime frame
1) Correlation between the fluorescent positive sites of 5-aminolevulinic acid, an intraoperative fluorescent probe used in surgery for cases suspected of having malignant glioma, and the uptake sites of fluciclovine PET. 2) Evaluation of the difference in fluciclovine accumulation between malignant glioma and tumors that require differentiation, and the ability to differentiate between them.

Contacts

Public ContactShuichiro Hirano

Okayama University Hospital

me421069@s.okayama-u.ac.jp+81-86-235-7336

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026