NCT07062549

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
38mo left

Started Jan 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2022Jul 2029

Study Start

First participant enrolled

January 26, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5.4 years

First QC Date

June 25, 2025

Last Update Submit

July 17, 2025

Conditions

Renal Cell Carcinoma (Kidney Cancer)

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    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.

    From enrollment to the end of treatment at 1 week

Secondary Outcomes (4)

  • Biodistribution assessed by SPECT/CT images

    From enrollment to the end of treatment at 1 week

  • Radiation Dosimetry assessed by SPECT/CT images

    From enrollment to the end of treatment at 1 week

  • Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time

    From enrollment to the end of treatment at 1 week

  • Number of lesions detected

    From enrollment to the end of treatment at 1 week

Study Arms (1)

A (111In-XYIMSR-01)

EXPERIMENTAL

Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging

Drug: 111In-XYIMSR-01

Interventions

111In-XYIMSR-01DRUG

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

A (111In-XYIMSR-01)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellKidney Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Yasser Ged, MBBS

    Johns Hopkins University SKCCC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasser Ged, MBBS

CONTACT

410-955-8893yged1@jhmi.edu

Jasmine Brooks

CONTACT

jbrook54@jhmi.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 14, 2025

Study Start

January 26, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

US(1)