First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 u…
Interventions
- Drug111In-XYIMSR-01
Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access
Location
- Johns Hopkins UniversityBaltimore, Maryland