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Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07062549•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Key Dates

Start Date

January 26, 2022

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2029

Last Updated

July 23, 2025

Enrollment

ESTIMATED participants

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Interventions

111In-XYIMSR-01

DRUG

Contacts

Yasser Ged, MBBS

CONTACT

410-955-8893 yged1@jhmi.edu

Jasmine Brooks

CONTACT

jbrook54@jhmi.edu

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NCT07485114

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Symptomatic and Incidental RCC Detection

Development and Validation of RCC Predicting Model With Emulated-target Trial