RECRUITING

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

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Conditions

Renal Cell Carcinoma (Kidney Cancer)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-01-26
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07062549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or female sex
  2. * ≥18 years of age
  3. * Willingness to provide signed informed consent and comply with all protocol requirements
  4. * Histological confirmation of RCC with a clear cell component
  5. * 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
  6. * Screening clinical laboratory values as specified below:
  7. * Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted
  8. * ALT ≤ 3 times the upper limits of normal
  9. * AST ≤ 3 times the upper limits of normal
  10. * Creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula
  11. * Absolute neutrophil count ≥ 1,500 /mm3
  12. * Platelets ≥100,000/ mm3
  13. * Hemoglobin ≥ 9.0 g/dL
  14. * White blood cell count ≥ 2,000/ mm3
  1. * Systemic therapy for the treatment of ccRCC within 12 months of study enrollment.
  2. * Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
  3. * Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
  4. * 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.
  5. * Women must not be breastfeeding.

Contacts and Locations

Study Contact

Yasser Ged, MBBS
CONTACT
410-955-8893
yged1@jhmi.edu
Jasmine Brooks
CONTACT
jbrook54@jhmi.edu

Principal Investigator

Yasser Ged, MBBS
PRINCIPAL_INVESTIGATOR
Johns Hopkins University SKCCC

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-26
Study Completion Date2029-07

Study Record Updates

Study Start Date2022-01-26
Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

  • Renal Cell Carcinoma (Kidney Cancer)