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New PET scan tracer could sharpen detection of liver spread in colorectal cancer

NCT ID NCT06935149

Diagnosis Sponsor: Primo Biotechnology Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether a new imaging tracer called 18F-PSMA-1007 can better detect liver metastases in people with colorectal cancer. Participants receive an injection of the tracer and then undergo a PET/CT scan. The goal is to see if this method finds the same liver lesions as standard imaging tools like CT or MRI. If it works, it could offer a more precise way to stage cancer and guide treatment.

What this could mean

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

Active substance
18F-PSMA-1007 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could help doctors more accurately detect liver metastases in colorectal cancer patients, guiding better treatment decisions.
What could go wrong
This is a very early, small study with only 5 participants, so results may not apply broadly. The tracer may not detect all lesions, and there are risks from radiation exposure.

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

5 people

The number who actually took part.

Started

Oct 2025

Finished

Jun 2026

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

20 to 100 years

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.

Main inclusion criteria: 1. The participants can voluntarily sign informed consent forms 2. The participants are male/female over 20 years old. 3. The participant is currently undergoing cancer staging based on the previous pathological diagnosis of colorectal cancer 4. The participants are confirmed liver metastasis by CT, abdominal ultrasound, MRI, and FDG PET/CT within 30 days before receiving PSMA-PET/CT. 5. WHO performance status ≦ 2 points 6. The participants can lie on table for two hours during PSMA-PET/CT scanning. Main exclusion criteria: To improve the accurate interpretation of PMSA-PET imaging and reduce the occurrence of related-drug adverse events, the participants will be excluded by following below criteria. 1. The colorectal cancer participants was diagnosed other organs metastases with multiple organ metastases not only the liver. 2. The colorectal cancer participants have undergone any treate after diagnosis of liver metastasis. 3. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months. 4. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months. 5. The participants suffered acute kidney injury within 6 months. 6. The participants suffered trauma or fracture. 7. The participants are allergic to any radiopharmaceutical or imaging agent. 8. The participants are history of claustrophobia or are inability to remain quiet during the examination.

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma metastasis from malignant tumor of colon

As listed by the trial registrant

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

Liver metastasis colon cancer

Contacts and locations

Locations

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401, Taiwan

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