111In-XYIMSR-01 SPECT/CT to find metastatic clear-cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional imaging trial gives adults with histologically confirmed clear-cell renal cell carcinoma a single dose of the investigational radiotracer 111In-XYIMSR-01 followed by SPECT/CT imaging to visualize sites of disease. Eligible participants must have 2–10 measurable lesions ≥1.5 cm on recent contrast CT or MRI and meet specified laboratory safety criteria. The study will document the tracer's ability to detect known lesions and collect safety and imaging-dosimetry data. Conducted at Johns Hopkins, the protocol excludes patients who received systemic therapy for ccRCC within the prior 12 months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Yasser Ged, MBBS — Johns Hopkins University SKCCC
• Study coordinator: Yasser Ged, MBBS
• Email: yged1@jhmi.edu
• Phone: 410-955-8893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.