89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE

Inclusion Criteria:

1. Written informed consent
2. Male or female \>50 years of age
3. Clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up or patients with established diagnosis of CCRC requiring imaging for recurrent disease
4. Life expectancy of at least 6 months
5. Consent to practise double-barrier contraception until end of study (7 days after 89Zr-girentuximab injection)

Exclusion Criteria:

1. Known hypersensitivity to girentuximab
2. Known uncontrolled hyperthyreoidism
3. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab
4. Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab.
5. Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03)
6. Planned (for the period between injection of 89Zr-girentuximab and imaging) antineoplastic therapies
7. Established renal cell carcinomas of other histological entities than CCRC
8. Known brain metastases
9. 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 patient, as judged by the investigator
10. 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 double-barrier 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 30 days (corresponding to 8 half-lives of 89Zr) after receiving study drug.
11. Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders)