FL-091 NTSR1-targeted imaging for finding and staging NTSR1-positive tumors

Clinical Application of FL-091 Radionuclide Imaging in Diagnosis and Staging of Malignant Tumors

This project will test whether a new NTSR1-targeted imaging agent called FL-091 can help find and stage NTSR1-expressing cancers in adults.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06977945 on ClinicalTrials.gov

What this trial studies

This is an observational imaging effort using FL-091, a radionuclide-conjugated probe that binds neurotensin receptor 1 (NTSR1). Adults with suspected or confirmed malignant tumors known to overexpress NTSR1 (for example colorectal, pancreatic, gastric, and head and neck cancers) will receive the FL-091 tracer and undergo positron imaging. Imaging results will be compared with standard imaging, laboratory markers, and pathology where available to determine how well FL-091 localizes and stages disease. The protocol is non-therapeutic and all procedures will be performed at the enrolling hospital.

Who should consider this trial

Good fit: Adults (18+) with suspected or confirmed malignant tumors that are likely to express NTSR1 who can give informed consent and meet required laboratory and contraception criteria.

Not a fit: Patients whose tumors do not express NTSR1, pregnant or breastfeeding individuals, or those unable to undergo radionuclide imaging are unlikely to benefit from this imaging approach.

Why it matters

Potential benefit: If successful, FL-091 imaging could allow earlier and more accurate detection and staging of NTSR1-expressing tumors, improving clinical decision-making.

How similar studies have performed: Related NTSR1-targeted probes have shown promising results in preclinical and early clinical work, but FL-091 is a newer agent with limited prior human data.

Eligibility criteria

Inclusion Criteria:

Each subject must meet all enrollment criteria to be eligible to participate in the study:

1. The subject or his/her legal representative is able to sign and date the informed consent form;
2. A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
3. Adult patients or healthy volunteers (aged 18 or above) of either sex;
4. Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
5. Consistent with the results of specific laboratory tests;
6. Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
7. Other set entry criteria.

Exclusion Criteria:

All subjects who meet any of the exclusion criteria baseline will be excluded from the study:

1. Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
2. Having other comorbidities;
3. Patients with known hypersensitivity to FL-091 fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
4. Have a history of comorbid drug use;
5. Patients considered by the investigator to have poor compliance;
6. Patients during pregnancy or lactation;
7. Persons with other factors that make participation in this test inappropriate.

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital,China — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaoli Lan, PhD

Conditions Malignant Tumors With Positive NTSR1 Expression