An Investigational Scan (111In-XYIMSR-01 SPECT/CT) for Tumor Detection in Patients with Metastatic Clear Cell Renal Cell Cancer

Inclusion Criteria

• Males or female sex
• ≥ 18 years of age
• Willingness to provide signed informed consent and comply with all protocol requirements
• Histological confirmation of RCC with a clear cell component
• 2-10 sites of disease measuring ≥ 1.5 cm on contrast-enhanced CT and/or magnetic resonance imaging (MRI) imaging of the chest, abdomen and pelvis performed ≤ 60 days prior to the date of study enrollment
• Serum bilirubin ≤ 1.5 times the upper limit of normal
• Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal
• Aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
• Estimated glomerular filtration rate ≥ 90 ml/min/1.73 m^2
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelets ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• White blood cell count ≥ 2,000/mm^3

Exclusion Criteria

• Systemic therapy for the treatment of ccRCC within 12 months of study enrollment
• Subjects administered any radioisotope within five physical half-lives prior to study drug injection
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion
• Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the imaging day
• Women must not be breastfeeding