A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
NCT07691775 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-07-09
Summary
This Phase I/II clinical study, titled "A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors", aims to evaluate the safety and diagnostic performance of F18 FBPA PET/CT imaging in subjects with solid tumors. The primary objective is to evaluate the safety and establish the optimal screening conditions (including dose, timing and image quality) of F18 FBPA PET/CT in patients with solid tumors.
Conditions
Interventions
- DRUG
-
F18 FBPA Injection
F18 FBPA (4-Borono-2-\[18F\]fluoro-L-phenylalanine) is a radiolabeled phenylalanine analog used in positron emission tomography (PET) for tumor imaging. Its uptake is mainly facilitated by the L-type amino acid transporter 1 (LAT1), which is commonly overexpressed in malignant tumors. This selective transport mechanism allows F18 FBPA to accumulate preferentially in tumor tissues rather than in normal tissues. Once taken up by cells, the fluorine-18 isotope emits positrons, enabling accurate visualization of tracer distribution through PET imaging.
Sponsors & Collaborators
-
Heron Neutron Medical Corp.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-20
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- Taiwan
Study Locations
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