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Can a single injection reveal hidden kidney cancer?

NCT ID NCT07768306

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental imaging agent called 68Ga-NYM096 in 20 adults who have a kidney mass of uncertain nature seen on CT or MRI and are scheduled for surgery. The agent is designed to attach to a protein common on clear cell renal cell carcinoma cells, potentially making them visible on a PET scan. The study aims to check the agent's safety, how it moves through the body, and whether it can help identify cancer before surgery.

What this could mean

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

Active substance
68Ga-NYM096 injection, an experimental imaging agent that targets a protein (CAIX) often found on clear cell renal cell carcinoma cells, given as a single intravenous injection before a PET scan.
What this could lead to
If successful, this could lead to a non-invasive PET imaging test that helps doctors tell cancerous from non-cancerous kidney masses without surgery, guiding treatment decisions.
What could go wrong
This is an early Phase 1 study with only 20 participants, so safety and diagnostic accuracy are not yet established. The imaging agent may not reliably distinguish cancer from benign tissue, and there are potential risks from radiation exposure and the injection itself.

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 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

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 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: 1. Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096. 2. Age ≥18 years at the time of signing the informed consent form; 3. ECOG score 0-2; 4. Life expectancy ≥6 months; 5. Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing; 6. Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures Exclusion Criteria: 1. A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM; 2. Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer. 3. Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides. 4. Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT. 5. Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer. 6. Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance. 7. Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus \[HCV\] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies). 8. Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination. 9. Other situations where the investigator considers the participant unsuitable for this 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

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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