Solid Tumor
Conditions
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.
Interventions
DRUGF18 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
Heron Neutron Medical Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject aged 18-80 (inclusive). 2. 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). 3. At least one measurable lesion identified on prior imaging evaluation, assessed by RECIST version 1.1. 4. Willingness to undergo PET/CT scan. 5. Provision of signed informed consent.
Exclusion criteria
1. Body weight \> 80 kg at screening. 2. Any contraindication to PET, including active breastfeeding. Female subjects of reproductive potential must have a negative serum pregnancy test at screening. 3. History of claustrophobic reactions. 4. History of phenylketonuria. 5. History of research-related radiation exposure exceeding the Nuclear Safety Commission's current guideline of 50 mSv within the past 12 months. 6. 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). 7. Subjects from other at-risk populations, including minors, cognitively impaired individuals. 8. Suspected or known hypersensitivity (including allergy) to any F18 FBPA components or contrast media 9. Hereditary fructose intolerance. 10. 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. 11. 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 12. 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. 13. History of radiation therapy within 3 months prior to the screening visit. 14. History of renal impairments, including nephrolithiasis, nephrotic syndrome, or hematuria, and/or other severe renal conditions in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types. | 6 months | To assess the added diagnostic value of F18 FBPA PET/CT for lesion detection and its correlation with clinical staging. |
Countries
Taiwan
Outcome results
None listed