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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT07691775

Run by

Heron Neutron Medical Corp.

People needed

30

Starts

2026-05-20

Expected to finish

2026-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Taipei Veterans General Hsopital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.