Solid TumorPhase 1/2NCT07691775
A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
A Phase 1/2 study testing F18 FBPA Injection in people with Solid Tumor, run by Heron Neutron Medical Corp. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- F18 FBPA Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2026to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hsopital
Taipei
YuhFeng Wang, (02)28757301, yfwang6@vghtpe.gov.tw
About this study
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
- Being tested
- F18 FBPA Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18 FBPA InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| F18 FBPA Injection | Experimental | Single arm treated by F18 FBPA Injection only Receives: Drug: F18 FBPA Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.
To assess the added diagnostic value of F18 FBPA PET/CT for lesion detection and its correlation with clinical staging.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start20 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heron Neutron Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691775
- Sponsor's protocol ID
- HN-FBPA-001
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors
- ClinicalTrials.gov ID
- NCT07691775
- Acronym / sponsor ID
- HN-FBPA-001
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heron Neutron Medical Corp.Industry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F18 FBPA Injection | Experimental | Drug: F18 FBPA InjectionSingle arm treated by F18 FBPA Injection only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F18 FBPA InjectionF18 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. | Drug | F18 FBPA Injection |
Primary outcome
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
Time frame: 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.
1 secondary outcome
To evaluate the applicability of F18 FBPA PET/CT imaging for tumor detection across various solid tumor types.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing F18 FBPA Injection in people with Solid Tumor, run by Heron Neutron Medical Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.