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
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
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.
Single group
111In-XYIMSR-01
DrugUnite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access
Number of adverse events
To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.
Biodistribution assessed by SPECT/CT images
To determine the biodistribution and radiation dosimetry of 111In-XYIMSR-01
Radiation Dosimetry assessed by SPECT/CT images
To determine radiation dosimetry of 111In-XYIMSR-01
Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time
To quantify the total radioactivity (expressed in counts per minute \[CPM\]) in plasma samples at specified time points following injection of 111In-XYIMSR-01
Number of lesions detected
Investigating the role of 111In-XYIMSR-01 SPECT/CT as a diagnostic assessment tool in comparison to conventional imaging. To compare the number of lesions detected with 111In-XYIMSR-01 SPECT/CT in comparison to conventional imaging all imaging modalities
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