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Evaluation of Safety, Pharmacokinetics, Distribution，Radiation Safety and Sensitivity/Specificity of PET/CT Imaging With 68Ga-NYM096 in Participants With IRM

NCT07768306 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-17

No results posted yet for this study

Summary

68Ga-NYM096 is a carbonic anhydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for the detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study is to evaluate the safety, pharmacokinetics, radioactivity distribution, radiation safety and preliminary diagnostic performance in participants with indeterminate renal masses (IRM)

Conditions

  • Clear Cell Renal Cell Carcinoma (ccRCC)

Interventions

DRUG

68Ga-NYM096 injection

Using a syringe to withdraw 68Ga-NYM096 injection, the dose will be administered via an intravenous injection

Sponsors & Collaborators

  • Norroy Bioscience Co., LTD

    lead INDUSTRY

Principal Investigators

  • Li Huo, MD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-03-31
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768306 on ClinicalTrials.gov