Study of 111In-XYIMSR-01 for Clear Cell Renal Cell Carcinoma

This study is looking at a new investigational radiotracer called 111In-XYIMSR-01. The goal is to see if this substance can help doctors better detect clear cell renal cell carcinoma (a type of kidney cancer) in your body when used with a SPECT-CT scan. You may be able to join if you are 18 or older, have clear cell renal cell carcinoma, and have 2-10 sites of disease that are at least 1.5 cm. The main way success will be measured is by tracking any side effects you might experience from the time you enroll until one week after treatment. The current recruitment status is unclear, and the study plans to enroll 6 participants.

Study design
This is an interventional study planning to enroll 6 participants. The study is testing 111In-XYIMSR-01.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events from enrollment to the end of treatment at 1 week.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07062549

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

Recruiting
PHASE1Ages 18+Interventional
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~6 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:111In-XYIMSR-01

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events
Measured over From enrollment to the end of treatment at 1 week
Renal Cell Carcinoma (Kidney Cancer)

NCT07062549

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins University

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Yasser Ged, MBBS · PRINCIPAL_INVESTIGATOR · Johns Hopkins University SKCCC

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Eligibility criteria

Inclusion

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

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.
  • Number of adverse eventsFrom enrollment to the end of treatment at 1 week

    To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.