Actively Recruiting
First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-23
6
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational radiotracer called 111In-XYIMSR-01 to see if it helps detect clear cell renal cell carcinoma (a type of kidney cancer) tissue in the body using a SPECT-CT scan. This is a phase 1 study focused on patients with metastatic clear cell renal cell carcinoma. The goal is to determine how well this radiotracer identifies cancerous tissue and to assess its safety. Participants receive a single intravenous dose of 10.5±1 mCi of 111In-XYIMSR-01 through a catheter placed in a vein, followed by SPECT/CT imaging. The study involves only one treatment group where all participants undergo this imaging procedure after dosing. The study period includes the dosing and imaging phase. During the study, participants will be monitored for adverse events from enrollment until one week after treatment. Researchers will assess how the radiotracer spreads throughout the body and measure radiation exposure using the SPECT/CT images. Blood samples will be taken to measure the concentration of the radiotracer over time. The number of cancer lesions detected will also be recorded. Participants' safety and treatment effects will be closely observed during this one-week period.
CONDITIONS
Brief Title
Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females 18 years of age or older
- Willingness to provide signed informed consent and follow all study requirements
- Histological confirmation of renal cell carcinoma with a clear cell component
- 2 to 10 cancer sites measuring at least 1.5 cm on recent CT or MRI scans within 60 days before enrollment
- Laboratory values within specified limits: serum bilirubin, ALT, AST, creatinine clearance, neutrophil count, platelets, hemoglobin, and white blood cell count as detailed in the protocol
You will not qualify if you...
- Received systemic therapy for clear cell renal cell carcinoma within 12 months before enrollment
- Received any radioisotope within five physical half-lives before study drug injection
- Any medical condition or circumstance that may affect data reliability or study completion
- Women of child-bearing potential without a negative pregnancy test within 24 hours prior to imaging
- Women who are breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive an intravenous dose of 111In-XYIMSR-01 followed by SPECT/CT imaging to assess biodistribution and radiation dosimetry.
1 dosing visit and imaging session plus follow-up assessments during the week
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
Y
Yasser Ged, MBBS
J
Jasmine Brooks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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