89Zirconium-labelled girentuximab (89Zr-TLX250) is a new diagnostic imaging agent which has a radionuclide (zirconium-89) linked with a drug known as girentuximab. The drug is known to be taken up by clear cell renal cell carcinoma. This product would be administered and then a scan of the body made by a PET/CT machine. This study is to determine the ability of the administered zirconium-89 girentuximab to correctly identify the nature of the known or suspected cancer within your kidney.
- Conditions
- Patients with an indeterminate renal mass (IRM) detected on contrast-enhanced abdominal MR imaging or equivalent standard of care imaging, clinically suspicious for renal cell carcinoma and scheduled for lesion resection as part of the regular diagnostic work-up/clinical care.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2018-002773-21-GB
- Lead Sponsor
- TELIX International Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 252
All patients must meet all of the following criteria:
1. Written and voluntarily given informed consent
2. Male or female = 18 years of age
3. Imaging evidence of a single indeterminate renal mass of = 7 cm in largest diameter (tumour stage cT1), on MRI or equivalent standard of care imaging, with contrast agent, not older than 90 days on Day 0, but performed before any screening procedure, suspicious for ccRCC.
4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration.
5. Negative serum pregnancy tests in female patients of childbearing potential at screening and confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
6. For patients included in France only, verification and confirmation of their affiliation with a social security
7. Sufficient life expectancy to justify nephrectomy.
8. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84
A patient will be excluded from participation in the trial if one or more of the following criteria are met:
1. A bioptic procedure only (rather than partial or total nephrectomy) planned for histological species delineation of IRM
2. Renal mass known to be a metastasis of another primary tumour.
3. Active non-renal malignancy requiring therapy during the time frame of the study participation.
4. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
5. Planned antineoplastic therapies (for the period between administration of 89Zr-TLX250 and imaging).
6. Exposure to murine or chimeric antibodies within the last 5 years.
7. Previous administration of any radionuclide within 10 half-lives of the same
8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
9. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr TLX250
11. Women who are pregnant or breastfeeding.
12. Known hypersensitivity to girentuximab or DFO (desferoxamine)
13. Renal insufficiency with GFR = 60 mL/min/ 1.73 m²
14. Vulnerable patients (e.g. being in detention)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method