68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal … (NCT06949215) | Clinical Trial Compass
Not Yet RecruitingPhase 2
68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
39 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 y
✓. Presence of complex renal cyst (Bosniak category II or higher)
✓. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
✓. Expected survival of at least 3 months
✓. ECOG ≤ 2
✓. Written informed consent provided for participation in the trial
✓. In the opinion of investigator, willing and able to comply with required study procedures.
Exclusion criteria
✕. On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM096. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
✕. Intercurrent medical condition that renders the patient ineligible for surgery.
What they're measuring
1
Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT
Timeframe: From study completion to 1 month after completion
2
Histological classification of operated renal lesions
Timeframe: From study completion to 1 month after completion