Actively Recruiting
Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Led by The Affiliated Hospital of Qingdao University · Updated on 2025-04-29
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Affiliated Hospital of Qingdao University
Lead Sponsor
Q
Qianfoshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of 18F-NY104 PET/CT scans in detecting primary, recurrent, and metastatic lesions in patients with renal cell carcinoma (RCC). This study also investigates how a low dose of an oral CAIX inhibitor, Acetazolamide, affects the distribution of 18F-NY104 in tissues, particularly in the stomach and kidneys. RCC is an aggressive kidney cancer with rising incidence, often diagnosed late, making better imaging methods important for early diagnosis and treatment planning. The study uses the radioactive tracer 18F-NY104 labeled with \[18F\]AlF for PET/CT imaging. All participants will receive an 18F-NY104 PET/CT scan to assess tumor location and progression. This imaging agent targets carbonic anhydrase IX (CAIX), which is highly expressed in RCC tumors. The study includes adult patients clinically diagnosed or suspected of RCC or its recurrence/metastasis, with measurable solid lesions. Participants will undergo PET/CT scans and clinical assessments during the study. Researchers will measure the standardized uptake value (SUV) over two years to evaluate the imaging agent's performance. Laboratory tests, performance status, and survival expectations will be monitored. The study aims to support better diagnosis and staging of RCC through detailed imaging and tissue distribution analysis of the tracer.
CONDITIONS
Brief Title
Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Aged between 18 and 75 years, any gender
- Clinically diagnosed or suspected renal cell carcinoma, including recurrence or metastasis
- At least one measurable solid lesion suitable for continuous measurement
- ECOG performance status score between 0 and 2
- Laboratory values within required ranges for blood counts, liver and kidney function
- Expected survival of at least 12 weeks
- Effective contraception used during the study and for 6 months after for females; males agree to contraception during the same period
You will not qualify if you...
- Recovery from major trauma or surgery within 4 weeks prior to the study
- Severe infections or serious other health conditions
- Severe liver or kidney dysfunction
- Refusal to participate in the study
- History of allergy to any imaging agent component or allergic constitution
- Childbearing-aged participants unable to use effective contraception
- Women who are pregnant, planning pregnancy, or breastfeeding
- Inability or unwillingness to undergo PET/CT scanning
- Other conditions deemed unsuitable by the investigator
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 undergo the 18F-NY104 PET/CT scan to detect and monitor renal cell carcinoma lesions.
1 visit (in-person)
Duration - 2 years
Participants are observed for up to 2 years to monitor tumor status and outcomes using SUV measurements.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
Research Team
G
guang Zhen Wang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here