REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT

Exclusion Criteria

• •1. Renal mass known to be a metastasis of another primary tumor.
• •2. Known histology of renal mass (e.g. by biopsy).
• •3. Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
• •4. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (\>grade 1) from such therapy.
• •5. Exposure to murine proteins or chimeric antibodies within the last 5 years.
• •6. Intercurrent medical condition that may limit patient's study participation or compliance.
• •7. History of autoimmune hepatitis.
• •8. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• •9. Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
• •10. Women who are pregnant or breastfeeding.
• •11. Contraindication to KI intake (see package insert/Appendix VI).
• •12. Hyperthyroidism, or Grave's Disease.
• •13. Contraindication for PET/CT.