Renal Cell Carcinoma (Kidney Cancer)
Conditions
Brief summary
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
DRUG111In-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
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution assessed by SPECT/CT images | From enrollment to the end of treatment at 1 week | To determine the biodistribution and radiation dosimetry of 111In-XYIMSR-01 |
| Radiation Dosimetry assessed by SPECT/CT images | From enrollment to the end of treatment at 1 week | To determine radiation dosimetry of 111In-XYIMSR-01 |
| Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time | From enrollment to the end of treatment at 1 week | To quantify the total radioactivity (expressed in counts per minute \[CPM\]) in plasma samples at specified time points following injection of 111In-XYIMSR-01 |
| Number of lesions detected | From enrollment to the end of treatment at 1 week | Investigating the role of 111In-XYIMSR-01 SPECT/CT as a diagnostic assessment tool in comparison to conventional imaging. To compare the number of lesions detected with 111In-XYIMSR-01 SPECT/CT in comparison to conventional imaging all imaging modalities |
Countries
United States
Contacts
CONTACTYasser Ged, MBBS
CONTACTJasmine Brooks
PRINCIPAL_INVESTIGATORYasser Ged, MBBS
Johns Hopkins University SKCCC
Outcome results
None listed