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New imaging tracer could spot kidney cancer without a needle

NCT ID NCT06090331

Diagnosis Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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) This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program gives patients with kidney masses access to a radioactive tracer called 89Zr-DFO-girentuximab, which is used with a PET/CT scan to detect clear cell renal cell carcinoma (a common kidney cancer) without surgery. The tracer attaches to a protein (CAIX) often found on these cancer cells, making them visible on the scan. The goal is to provide a non-invasive diagnostic option for patients who have suspicious kidney masses seen on standard CT or MRI.

What this could mean

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

Active substance
89Zr-DFO-girentuximab (a radioactive tracer for PET/CT imaging)
What this could lead to
If successful, this imaging method could provide a non-invasive way to detect clear cell renal cell carcinoma, potentially reducing the need for biopsies.
What could go wrong
This is an expanded access program, not a formal trial, so data on effectiveness and safety are limited. The tracer may not accurately distinguish all cancer types, and radiation exposure is a risk.

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.

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 to 99 years

Sex

Anyone

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. Written and voluntarily given informed consent. 2. Male or female ≥ 18 years of age. 3. Imaging evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI (without and with contrast enhancement) based on national standards that is not older than 90 days on Day 0, and that was performed before any screening procedure. 4. Negative urine/serum pregnancy tests in female patients of childbearing potential. 5. Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration. Exclusion Criteria: 1. Renal mass known to be a metastasis of another primary tumor. 2. Active non-renal malignancy requiring therapy during and up to EOT visit. 3. Radiotherapy or immunotherapy within 4 weeks (28 days) prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (\> grade 1 using Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from such therapy. 4. Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging). 5. Previous administration of any radionuclide within 10 of its half-lives before Day 0. 6. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator. 7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program. 8. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-DFO-girentuximab. 9. Women who are pregnant or breastfeeding. 10. Known hypersensitivity to girentuximab or DFO (desferoxamine).

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Conditions

The condition(s) this trial relates to.

kidney neoplasm nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

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

Clear cell renal cell carcinoma

Contacts and locations

Locations

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Austin Radiological Association

    Austin, Texas, 78705, United States

  • Biogenix Molecular

    Miami, Florida, 33165, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Bloomington, Indiana, 47405, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66103, United States

  • Kettering Health Main Campus

    Kettering, Ohio, 45429, United States

  • M Health Fairview/ University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77054, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34243, United States

  • Stanford Urologic Cancer Program

    Palo Alto, California, 94304, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • United Theranostics

    Glen Burnie, Maryland, 21061, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32209, United States

  • Urology Associates, PC

    Nashville, Tennessee, 37209, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Xcancer

    Omaha, Nebraska, 68130, United States

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