NCT06949215

68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision

68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.

Detailed description

This is a prospective, single-center, single-arm, diagnostic phase 2 study designed to evaluate the efficacy of 68Ga-NYM096 PET/CT in detecting clear cell renal carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Prior to tumor resection, contrast-enhanced CT imaging of the abdomen will be conducted, and if clinically indicated or as part of the local standard of care, imaging of the chest will also be performed. Both imaging modalities (68Ga-NYM096 PET/CT and diagnostic CT) will be completed before kidney resection. The PET/CT images will be independently interpreted by two blinded readers, while the diagnostic CT images will be evaluated by one blinded reader. The interpretations from both imaging modalities will be compared with histopathologic findings to estimate sensitivity, specificity, and predictive values (primary and secondary objectives). Additionally, the study will explore the performance of 68Ga-NYM096 PET/CT in detecting metastases compared to diagnostic CT. This study aims to provide insights into the diagnostic accuracy of 68Ga-NYM096 PET/CT for identifying ccRCC in patients with complex renal cysts. The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression. 39 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Conditions

• ccRCC
• Complex Renal Cyst

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-NYM096 PET/CT	Participants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM096 administration.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-08-01
• Completion: 2027-07-01
• First posted: 2025-04-29
• Last updated: 2025-04-29