Can a single injection reveal hidden kidney cancer?
NCT ID NCT07768306
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Clear cell renal cell carcinoma (CCRCC) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
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.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive tracer aims to spot kidney cancer with sharper eyes
- New Immune-Boosting drug combo targets Hard-to-Treat cancers
- New PET scan could spot hidden kidney cancer after treatment
- New drug combo may help save kidneys in High-Risk cancer patients
- New drug combo aims to shrink hard-to-treat tumors
- New imaging agent shows promise for kidney cancer detection