clear cell renal carcinoma kidney cancer
Conditions
Interventions
None listed
Sponsors
TELIX International Pty. Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients must meet all of the following criteria:;- Written informed consent - Male or female >50 years of age - Clinical suspicion of CCRC, based on incidental imaging evidence of a renal mass, requiring further diagnostic work-up (incidentalomas), or patients with established diagnosis of CCRC requiring staging - Life expectancy of at least 6 months - Consent to practise contraception until end of study (7 days after 89Zr-girentuximab injection)
Exclusion criteria
Exclusion criteria: A patient will be excluded from participation in the trial if one or more of the following criteria are met:;- Known hypersensitivity to girentuximab - Known uncontrolled hyperthyreoidism - Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab - Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab. - Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03) - Planned (for the period between injection of 89Zr-girentuximab and imaging) antineoplastic therapies - Established renal cell carcinomas of other histological entities than CCRC - Known brain metastases - 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 - Pregnant or breast-feeding women. Female patients of childbearing potential or male patients with female partners of childbearing potential, unless willing to practice full and true sexual abstinence or being surgically/permanently sterile or with a history of hysterectomy for women, not willing to practice effective contraception by using: a non-oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, during the study period and within a period of 28 days (corresponding to 8 half-lives of 89Zr) after receiving study drug. 11. Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study will be to evaluate clinical safety and tolerability of 89Zr-girentuximab. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine the whole body radiation dosimetry of 89Zr-girentuximab in patients with suspected CCRC - To assess diagnostic image quality of 89Zr-girentuximab using a time-of-flight PET (TOF-PET) compared a conventional PET (C-PET reconstruction) - To assess diagnostic image quality of 89Zr-girentuximab using a 37 MBq (1 mCi) activity dose and different acquisition durations (5, 10, 15 vs. 20 min) - To establish activity dose and recommended acquisition modalities for further clinical development | — |
Countries
Netherlands
Outcome results
None listed