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New PET tracer for prostate cancer enters human testing

NCT ID NCT07149831

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing a new imaging agent called Flotufolastat F-18 in 6 healthy Chinese adults. The tracer is designed to light up prostate cancer cells during PET scans. Researchers are checking how safe it is, where it goes in the body, and how much radiation it gives off. This is a first step before testing it in people with prostate cancer.

What this could mean

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

Active substance
Flotufolastat F-18 Injection
What this could lead to
If successful, this could lead to a more accurate PET imaging method for detecting prostate cancer, potentially improving diagnosis and treatment planning.
What could go wrong
This is a very early Phase I trial with only 6 healthy volunteers, not patients. It only tests safety and imaging properties, not whether it actually helps diagnose cancer better than existing methods.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

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

Started

Jun 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Have the ability to understand the content of study and voluntarily sign the informed consent form. 2. Healthy male or female, aged 18-60 (included). 3. Body mass index (BMI) between 19 and 26 kg/m² (included). 4. Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant. 5. Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant. 6. Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up. 7. Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed. Exclusion Criteria: 1. Claustrophobia or inability to tolerate imaging examinations for any other reason. 2. Have a history of epilepsy or seizures, excluding childhood febrile seizures. 3. With chronic diseases, including but not limited to: 1. cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof. 2. history of psychiatric disorders or currently significant psychiatric conditions 4. Have a history of asthma or allergies. 5. Have a history of malignant tumors. 6. Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant. 7. Underwent any surgical procedure within 3 months before administration or planned surgery during the study period. 8. Accomplished the blood donation or significant blood loss (\>400 mL) within 3 months before administration or during the screening period. 9. Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling). 10. Known allergy to the active ingredient or any excipients of the investigational product. 11. Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration. 12. Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer). 13. Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer). 14. Pregnant or breastfeeding women. 15. Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator. 16. QTc intervalis longer than 450 milliseconds during the screening period. 17. Major occupational exposure to ionizing radiation in the past 10 years (e.g., more than 50 mSv/year) or exposure to radioactive materials or ionizing radiation for therapeutic or research purposes. 18. Any reason determined by the investigator that could not complet the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100089, China

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