Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell
Purpose
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
Condition
- Renal Cell Carcinoma (Kidney Cancer)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental A (111In-XYIMSR-01) |
Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging |
|
Recruiting Locations
Johns Hopkins University
Baltimore, Maryland 21287
Baltimore, Maryland 21287
More Details
- Status
- Recruiting
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins