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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
Sponsor: Norroy Bioscience Co., LTD
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
Conditions
Interventions
68Ga-NYM096 injection
Using a syringe to withdraw 68Ga-NYM096 injection, the dose will be administered via an intravenous injection