68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Recruiting now · Phase 2
Conditions studied: ccRCC, Complex Renal Cyst
In brief
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.
Key facts
- Study ID
- NCT06949215
- Run by
- Peking Union Medical College Hospital
- People needed
- 70
- Starts
- 2025-05-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Where it is running
- Peking Union Medical College — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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