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NOT YET RECRUITING
NCT07768306
PHASE1

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

Sponsor: Norroy Bioscience Co., LTD

View on ClinicalTrials.gov

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)

Official title: A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution,Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09

Completion Date

2027-04

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DRUG

68Ga-NYM096 injection

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