68Ga-NYM096 PET/CT to Find ccRCC in Complex Renal Cysts Before Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm diagnostic Phase 2 study. It uses a single intravenous dose of 68Ga-NYM096 followed by whole-body PET/CT imaging to detect ccRCC in operable complex renal cysts, with histopathology after resection as the reference standard. The study also compares PET/CT findings to diagnostic CT for lesion characterization and to see if PET/CT can reveal metastases. Two blinded readers evaluate the PET/CT images while one blinded reader assesses the diagnostic CT images. The goal is to determine sensitivity, specificity, and predictive values for 68Ga-NYM096 PET/CT. Histology, grading, and CAIX expression will be recorded from resected tissue.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Li Huo, MD
• Email: huoli@pumch.cn
• Phone: +86 18612672038

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.