Recruiting NCT07062549
Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 111In-XYIMSR-01.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma (Kidney Cancer). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Overview
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
Interventions
- Drug 111In-XYIMSR-01
Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access
Primary outcome measures
- Number of adverse events [Time frame: From enrollment to the end of treatment at 1 week]
Secondary outcome measures (4)
- Biodistribution assessed by SPECT/CT images [Time frame: From enrollment to the end of treatment at 1 week]
- Radiation Dosimetry assessed by SPECT/CT images [Time frame: From enrollment to the end of treatment at 1 week]
- Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time [Time frame: From enrollment to the end of treatment at 1 week]
- Number of lesions detected [Time frame: From enrollment to the end of treatment at 1 week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins University — Baltimore
Identifiers
NCT: NCT07062549 · J20116 · IRB00237314