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Could a simple scan replace biopsies for key cancer marker?

NCT ID NCT06754345

Diagnosis Sponsor: The First Affiliated Hospital of Xiamen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new radioactive tracer called 68Ga-NK224 that lights up PD-L1, a protein on cancer cells, during a PET/CT scan. Researchers want to see if the scan can accurately measure PD-L1 levels compared to standard tissue biopsy. One hundred adults with various cancers will be scanned, and the results will be compared to their biopsy reports. If it works, this could offer a less invasive way to guide immunotherapy decisions.

What this could mean

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

Active substance
68Ga-NK224 (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could help doctors see PD-L1 levels in tumors without needing a biopsy, guiding better cancer treatment decisions.
What could go wrong
This is an early imaging study with 100 participants. It tests accuracy against biopsy results, so it may not change practice if the scan doesn't match well. No direct treatment benefit for participants.

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

May 2023

Expected to finish

Nov 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

(i) adult patients (aged 18 years or order); (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-NK224 PET/CT scans; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Ages

18 to 90 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: * (i) adult patients (aged 18 years or order); * (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); * (iii) patients who had scheduled 68Ga-NK224 PET/CT scans; * (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant lesions; * (ii) patients with pregnancy; * (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

cancer disease neoplasm

As listed by the trial registrant

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

PD-L1 Tumor

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

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361000, China

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