Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell

Summary

This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan

Eligibility

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 MRI imaging of the chest, abdomen and pelvis performed ≤60 days prior to the date of study enrollment
* Screening clinical laboratory values as specified below:

  * Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted
  * ALT ≤ 3 times the upper limits of normal
  * AST ≤ 3 times the upper limits of normal
  * Creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula
  * Absolute neutrophil count ≥ 1,500 /mm3
  * Platelets ≥100,000/ mm3
  * Hemoglobin ≥ 9.0 g/dL
  * White blood cell count ≥ 2,000/ mm3

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.

Conditions2

Locations1 site

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