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New radioactive tracer could sharpen cancer detection

NCT ID NCT06471712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase trial tested a new radioactive imaging agent called 18F-LNC1007 in 8 people—some healthy and some with a few small tumors. The goal was to see how the agent moves through the body, how much radiation it gives off, and whether it is safe. Participants received one injection and underwent PET/CT scans over several hours.

What this could mean

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

Active substance
18F-LNC1007 injection (a radioactive imaging agent)
What this could lead to
If successful, this could lead to a new PET/CT imaging method to better detect and monitor small tumors.
What could go wrong
This is a very early, small study (8 people) focused on safety and imaging properties, not treatment. It may not lead to a widely used diagnostic tool.

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

8 people

The number who actually took part.

Started

Jul 2024

Finished

Mar 2025

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 years and older

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. Express willingness and ability to comply with all study procedures and restrictions. 2. Be healthy adult volunteers, or light tumour burden cancer patients, as defined by \<5 lesions and MITV of \<10ml on a PET/CT performed for clinical purposes. Eligibility includes adults of any gender. 3. Have a Body Mass Index (BMI) between 19-28 (inclusive). 4. Be capable of lying on the scanner for the duration of the PET/CT procedure, which is approximately one hour. 5. Subjects must have an adequate organ function before the administration of the 18F-LNC1007 (in the absence of blood transfusion, hematopoietic stimulating and hepatoprotective agents), as defined by: 1. White blood cell (WBC) count ≥ 3×109/L or absolute neutrophil count (ANC) \> 1.5×109/L, platelets ≥ 100×109/L, hemoglobin (Hb) \> 10.0g/dL 2. Serum albumin \> 3.0 g/dL, total bilirubin \< 1.5×ULN, alanine aminotransferase (ALT) \< 3×ULN, aspartate aminotransferase (AST) \< 3×ULN 3. Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). 6. Provide informed signed consent. 7. All females of childbearing potential (defined as premenopausal or less than 2 years post-menopausal who have not undergone surgical sterilization) must undergo a blood pregnancy test during the screening period (within 7 days before the administration of the drug). The result of the pregnancy test must be negative. Exclusion Criteria: 1. Contraindications to PET/CT scan, which include, but are not limited to, conditions like claustrophobia and pregnancy. 2. A medical history of epilepsy or seizures, excluding febrile convulsions during childhood. 3. Blood donation or experienced major blood loss (\> 400 mL) within 3 months prior to the screening or during the study period. 4. For healthy volunteers: participants with a clinically significant disease or medical history as determined by the trial investigator. This includes, but is not limited to: 1. Conditions related to circulatory, respiratory, digestive, urinary, hematological, neurological, endocrine, and musculoskeletal systems. 2. History of mental disorders or any other disease with clinical significance. 3. History of major surgery or anticipated major surgery within 1 month prior to the screening or during the study period. 5. For healthy volunteers: medical comorbidities that may interfere with the absorption or metabolism of the investigational drug, limit the interpretation of the trial results, and/or are deemed clinically significant by the investigator. 6. For healthy volunteers: abnormal findings in physical examination, vital signs, laboratory tests, or 12-lead ECG during the screening period, considered clinically significant by the investigator (Baseline physical examination, laboratory tests, and 12-lead ECG can accept results from Day -7 to Day -1). 7. For healthy volunteers: use of any prescription drugs, over-the-counter drugs, or traditional herbal medicine within 14 days before administration. 8. Active and clinically significant bacterial, fungal, or viral infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness (patients with treated HIV and hepatitis B or C could be included). 9. Insufficient venous access (two different venous accesses are required for the injection of the experimental drug and PK blood sampling). 10. Female participants who are pregnant (positive pregnancy test at screening) or lactating, or are of childbearing potential (premenopausal or less than 2 years post-menopausal and have not undergone surgical sterilization), who do not agree to use effective contraception (such as complete abstinence, condom use, IUD, etc.) during the trial (from the signing of the informed consent) and for one month after administration. 11. Male participants with plans for procreation or sperm donation during the trial (from the signing of the informed consent) and one month after administration or who do not wish to take effective contraceptive measures (such as complete abstinence, condom use, surgical sterilization, etc.). 12. Subjects with a history of allergies that the investigator believes could increase the trial risk. 13. Clinically significant abnormalities on electrocardiogram (ECG) at screening including QTcF \> 470 ms, and subjects who cannot tolerate high volume load. 14. Subjects who have undergone radioactive drug imaging (other than 18F-FDG) or treatment within 7 days prior to screening. 15. Subjects who have participated in other clinical trials within the past 1 month before the screening visit. 16. Participation in clinical trials of radiopharmaceuticals within 1 year prior to screening. 17. History of long exposure to high-dose radiation. 18. Subjects with a history of drug or alcohol abuse within the past year or a long-term history of drug use. 19. For light tumor burden patients: concurrent anti-cancer treatment; 20. For light tumor burden patients: previous major surgeries or anticipated major surgery within 1 month prior to the screening or during the study period. 21. Other conditions that the investigator believes render the participant not suitable for participating in the trial.

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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.

Contacts and locations

Locations

  • Precision Molecular Imaging & Theranostics (trading as Melbourne Theranostic Innovation Centre)

    Melbourne, Australia

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