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New imaging agent could sharpen cancer detection

NCT ID NCT06977945

Diagnosis Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new imaging agent called FL-091, which targets a protein (NTSR1) found on some cancer cells. Researchers will use it with PET or SPECT scans to see if it can better detect and stage cancers like head and neck, colorectal, and pancreatic cancer. About 100 adults with suspected or confirmed NTSR1-positive tumors will take part. The goal is to see how well the agent highlights tumors and where it goes in the body, laying groundwork for future targeted treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FL-091 (a radionuclide imaging agent)
What this could lead to
If successful, this could lead to a more accurate way to detect and stage certain cancers, potentially guiding better treatment decisions.
What could go wrong
This is an early diagnostic study with only 100 participants, so results may not apply to all patients. The imaging agent's effectiveness and safety are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer head and neck cancer pancreatic adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant tumors with positive NTSR1 expression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wuhan Union Hospital,China

    RECRUITING

    Wuhan, Hubei, 430030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.