A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors

NCT07691775 | Recruiting Phase 1

• 1 other identifier: HN-FBPA-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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

  Safety: To evaluate the safety profile of F18 FBPA, all cohorts will undergo safety monitoring for up to one week following the F18 FBPA PET/CT scan. Monitoring will include routine assessments of adverse events (AEs), physical examinations, and vital signs. Diagnostic efficacy: To assess the diagnostic efficacy of F18 FBPA PET/CT by quantifying tracer uptake (SUVmax, SUVmean and SUVpeak), aiming to determine the minimum effective dose and optimal imaging timepoint.

  6 months

Secondary Outcomes (1)

• To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.

  6 months

Study Arms (1)

F18 FBPA Injection

EXPERIMENTAL

Single arm treated by F18 FBPA Injection only

Drug: F18 FBPA Injection

Interventions

F18 FBPA Injection DRUG

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.

F18 FBPA Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged 18-80 (inclusive).
• Histopathological confirmed diagnosis of a solid tumor (including but not limited to osteogenic sarcoma, brain tumors, head and neck cancer, lung cancer, breast cancer, or colorectal cancer).
• At least one measurable lesion identified on prior imaging evaluation, assessed by RECIST version 1.1.
• Willingness to undergo PET/CT scan.
• Provision of signed informed consent.

You may not qualify if:

• Body weight \> 80 kg at screening.
• Any contraindication to PET, including active breastfeeding. Female subjects of reproductive potential must have a negative serum pregnancy test at screening.
• History of claustrophobic reactions.
• History of phenylketonuria.
• History of research-related radiation exposure exceeding the Nuclear Safety Commission's current guideline of 50 mSv within the past 12 months.
• Inability to lie comfortably in a supine position for more than 60 minutes.as assessed by physical examination and medical history (e.g., back pain, severe arthritis).
• Subjects from other at-risk populations, including minors, cognitively impaired individuals.
• Suspected or known hypersensitivity (including allergy) to any F18 FBPA components or contrast media
• Hereditary fructose intolerance.
• A greater risk than normal for potential cardiac arrest such as history of non-compensated congestive heart failure, poorly controlled arrythmias or symptomatic non compensated cardiopathies.
• Inadequate organ function within 30 days prior to the F18 FBPA PET/CT, defined as:
• QTc \> 460 msec; Serum Albumin \< 2.8 mg/mL; Total Bilirubin \> 3.0 mg/mL; ALT ≥ 400 U/L and/or AST ≥ 400 U/L; Creatinine \< 0.5 mg/dL or \> 1.4 mg/dL; eGFR \< 60 mL/min/1.73 m2
• Any medical or psychiatric conditions under the supervision of the investigator may interfere with optimal participation in the study or place the subject at increased risk of AEs.
• History of radiation therapy within 3 months prior to the screening visit.
• History of renal impairments, including nephrolithiasis, nephrotic syndrome, or hematuria, and/or other severe renal conditions in the opinion of the investigator.

Sponsors & Collaborators

• Heron Neutron Medical Corp.: lead

Study Sites (1)

Taipei Veterans General Hsopital

Taipei, Taiwan

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TW (1)