Actively Recruiting
68Ga-NYM096 PET/CT for Detecting Clear Cell Renal Cell Carcinoma in Patients with Complex Cystic Renal Lesions Scheduled for Surgery
Led by Peking Union Medical College Hospital · Updated on 2026-05-26
70
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy of 68Ga-NYM096 PET/CT for detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts scheduled for surgical removal. This phase 2, single-center, single-arm study aims to compare PET/CT results with histopathological diagnosis to assess sensitivity and specificity. The goal is to determine how well 68Ga-NYM096 PET/CT can identify ccRCC non-invasively before surgery. Each participant will receive a single intravenous dose of 68Ga-NYM096, followed by whole-body PET/CT imaging about 45 to 75 minutes after injection. Before surgery, contrast-enhanced CT scans of the abdomen and chest (if indicated) will be performed. PET/CT and CT images will be evaluated independently by blinded readers, and results will be compared with tissue analysis after kidney resection. The study will also explore PET/CT's ability to detect metastases compared to CT. Participants will undergo PET/CT and CT imaging prior to kidney surgery. The pathologist will analyze tumor tissue for histology, grading, and CAIX expression. Researchers will assess diagnostic accuracy measures such as sensitivity, specificity, and predictive values within one month after study completion. The study involves 39 patients and follows ethical and regulatory standards. Participation includes imaging, surgery, and histological testing over the study period ending in 2027.
CONDITIONS
Brief Title
68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presence of complex renal cyst (Bosniak category II or higher)
- Scheduled for surgical removal of kidney mass (partial or total nephrectomy, any technique)
- Expected survival of at least 3 months
- ECOG performance status of 2 or less
- Provided written informed consent
- Able and willing to comply with study procedures as judged by investigator
You will not qualify if you...
- Received VEGF tyrosine kinase inhibitor treatment less than 1 week before 68Ga-NYM096 PET/CT
- Medical condition that makes surgery inadvisable
- Pregnancy or breastfeeding
- Severe claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous dose of 68Ga-NYM096 followed by dedicated whole-body PET/CT imaging and contrast-enhanced CT imaging prior to surgery to detect renal lesions and metastases.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo surgical removal of the kidney mass (partial or total nephrectomy) following diagnostic imaging.
1 surgical visit and post-operative care visits as per routine clinical practice
Duration - Up to 1 month
Participants are monitored for up to 1 month after surgery to assess histological classification and other outcomes from operated renal lesions.
Approximately 1 to 2 visits (in-person) during follow-up
Trial Site Locations
Total: 1 location
1
Peking Union Medical College
Beijing, China, 100730
Actively Recruiting
Research Team
L
Li Huo, MD
W
Wenjia Zhu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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