NCT07062549RecruitingPhase 1
Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell
First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 26 Jan 2022
- Primary completion date
- Jul 2027
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Kidney cancer
- NCT number
- NCT07062549
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From 26 Jan 2022 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Lab values
- 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.
Other
- Women must not be breastfeeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.