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A Single-Arm Clinical Trial to Evaluate the Diagnostic Performance of FACBC PET/CT in Differentiating Recurrent Brain Tumor from Post-Treatment Changes

A Single-Arm Clinical Trial to Evaluate the Diagnostic Performance of [F-18]fluciclovine (anti-1-amino-3-[18F]-fluorocyclobutane-1-carboxylic acid [FACBC]) PET/CT in Differentiating Recurrent Brain Tumor from Post-Treatment Changes - FACBC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250208
Enrollment
20
Registered
2025-07-03
Start date
2025-08-05
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

brain tumor

Interventions

FACBC PET/CT

Sponsors

Tateishi Ukihide
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with a history of radiotherapy and/or chemotherapy for brain tumors (regardless of the presence or absence of surgical history). 2.Patients suspected of recurrence on MRI (e.g., newly appearing or enlarging abnormal signal areas on MRI). 3.Patients aged 18 to 90 years at the time of obtaining informed consent. 4.Patients who have provided written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Patients with a known hypersensitivity to amino acids. 2.Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2). 3.Pregnant patients, patients who may be pregnant, or patients (or their partners) who wish to become pregnant. 4.Breastfeeding patients. 5.Patients who are considered unable to provide appropriate consent due to mental or legal reasons. 6.Patients who are judged by the principal investigator or sub-investigators to be inappropriate for participation in this study for any other reason.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of FACBC PET/CT for detecting brain tumor recurrence, using pathological diagnosis or clinical diagnosis as the reference standard.

Secondary

MeasureTime frame
1.Specificity 2.Sensitivity 3.Negative Predictive Value (NPV) 4.Positive Predictive Value (PPV) 5.Overall Survival (OS) Percentage of adverse events

Contacts

Public ContactKota Yokoyama

Institute of Science Tokyo Hospital

ykymdrnm@tmd.ac.jp+81-3-5803-5311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026