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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 68Ga-NYM096 PET/CT to see how well it can detect clear cell renal cell carcinoma (ccRCC) in patients who have complex renal cysts and are planning to have surgery. The trial aims to find out how accurately this non-invasive test can identify ccRCC compared to traditional methods, using actual tissue samples from surgery as the reference point. This research is important because it could help improve the way doctors diagnose ccRCC before surgery, making it easier for patients to get the right treatment.

To be eligible for this trial, participants need to be at least 18 years old and have a complex renal cyst that is categorized as significant. They must also be scheduled for surgery to remove the cyst and have a good chance of surviving for at least three months. Participants will need to provide written consent and be willing to follow the study procedures. It's important to note that people who have recently taken certain cancer medications or have conditions that prevent them from having surgery would not be eligible. The trial is not yet recruiting participants, but it represents a step forward in the non-invasive detection of ccRCC for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 y
• • 2. Presence of complex renal cyst (Bosniak category II or higher)
• • 3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
• • 4. Expected survival of at least 3 months
• • 5. ECOG ≤ 2
• • 6. Written informed consent provided for participation in the trial
• • 7. In the opinion of investigator, willing and able to comply with required study procedures.
• Exclusion Criteria:
• • 1. 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.
• • 2. Intercurrent medical condition that renders the patient ineligible for surgery.
• • 3. Pregnancy or breastfeeding.
• • 4. Severe claustrophobia.