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

RecruitingPhase 1Ages 18 Years - anyAllSidney Kimmel Comprehensive Cancer Center at John…
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • 111In-XYIMSR-01
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Where

1 site
Johns Hopkins University
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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