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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wuhan Union Hospital,China
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiaoli Lan, PhD
• Email: lxl730724@hotmail.com
• Phone: 0086-027-83692633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.