Clear Cell Renal Cell CarcinomaNCT06090331
89Zr-DFO-girentuximab Expanded Access Program (EAP)
A study testing 89Zr-DFO-girentuximab in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 22 sites in United States.
Trial summary
The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- 89Zr-DFO-girentuximab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 22 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Who may be able to join
- Written and voluntarily given informed consent.
- Male or female ≥ 18 years of age.
- 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.
- Negative urine/serum pregnancy tests in female patients of childbearing potential.
- Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.
Who cannot join
- Renal mass known to be a metastasis of another primary tumor.
- Active non-renal malignancy requiring therapy during and up to EOT visit.
- 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.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
- Previous administration of any radionuclide within 10 of its half-lives before Day 0.
- 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.
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- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-DFO-girentuximab.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or DFO (desferoxamine).
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Austin Radiological Association
Austin, Texas, 78705
Indiana University
Bloomington, Indiana, 47405
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
UT Southwestern
Dallas, Texas, 75390
United Theranostics
Glen Burnie, Maryland, 21061
MD Anderson Cancer Center
Houston, Texas, 77054
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, 32209
Kansas University Medical Center
Kansas City, Kansas, 66103
Kettering Health Main Campus
Kettering, Ohio, 45429
Arkansas Urology
Little Rock, Arkansas, 72211
UCLA
Los Angeles, California, 90095
Biogenix Molecular
Miami, Florida, 33165
M Health Fairview/ University of Minnesota
Minneapolis, Minnesota, 55455
Urology Associates, PC
Nashville, Tennessee, 37209
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Xcancer
Omaha, Nebraska, 68130
Stanford Urologic Cancer Program
Palo Alto, California, 94304
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Urology San Antonio
San Antonio, Texas, 78229
Sarasota Memorial Health Care System
Sarasota, Florida, 34243
Munson Medical Center
Traverse City, Michigan, 49684
About this study
Official title: An Expanded Access Program for the Non-invasive Detection of Clear Cell Renal Cell Carcinoma (ccRCC) in Patients With Renal Masses Utilizing 89Zirconium-labelled Girentuximab (89Zr-DFO-girentuximab)
The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- 89Zr-DFO-girentuximab
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFO-girentuximabDiagnostic test
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090331
- Sponsor's protocol ID
- 89Zr-TLX250-007
- Status last verified
- May 2026
- First submitted
- 12 Oct 2023
- Last updated
- 29 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program for the Non-invasive Detection of Clear Cell Renal Cell Carcinoma (ccRCC) in Patients With Renal Masses Utilizing 89Zirconium-labelled Girentuximab (89Zr-DFO-girentuximab)
- ClinicalTrials.gov ID
- NCT06090331
- Acronym / sponsor ID
- 89Zr-TLX250-007
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- clear cell renal cell carcinoma, PET/CT imaging, 89Zr-girentuximab
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written and voluntarily given informed consent.
- Male or female ≥ 18 years of age.
- 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.
- Negative urine/serum pregnancy tests in female patients of childbearing potential.
- Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.
Key exclusion criteria (10 listed)
- Renal mass known to be a metastasis of another primary tumor.
- Active non-renal malignancy requiring therapy during and up to EOT visit.
- 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.
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
- Previous administration of any radionuclide within 10 of its half-lives before Day 0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-DFO-girentuximabSingle IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days. | Diagnostic test | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 89Zr-DFO-girentuximab in people with Clear Cell Renal Cell Carcinoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.