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
85 weeks
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
Study on the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in diagnosing primary, recurrent, and metastatic lesions of renal cell carcinoma; and investigate the effect of oral low-dose CAIX inhibitor (Acetazolamide) on the tissue distribution of 18F-NY104 in renal cell carcinoma patients, particularly in the stomach and kidneys.
CONDITIONS
Official 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 the informed consent form and complete the trial as required
- Age between 18 and 75 years with no gender restrictions
- Clinically diagnosed or suspected renal cell carcinoma, or suspected recurrence/metastasis after RCC treatment
- At least one measurable solid lesion that can be accurately and continuously measured using modified RECIST criteria (version 1.1)
- ECOG performance status score of 0 to 2
- Laboratory requirements: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L; PT or APTT ≤1.5× upper limit of normal (ULN)
- Liver and kidney function within specified limits: total bilirubin ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN if liver metastasis present, alkaline phosphatase ≤2.5×ULN or ≤4.5×ULN if bone or liver metastasis present, blood urea nitrogen ≤1.5×ULN, serum creatinine ≤1.5×ULN
- Other routine tests within normal ranges or acceptable by investigator
- Expected survival of at least 12 weeks
- Female participants must use effective contraception during the study and for 6 months after; male participants must agree to use contraception during the same period
You will not qualify if you...
- Recovery from major trauma or surgery within 4 weeks before study examination
- Having systemic or local severe infections or serious comorbidities
- Severe liver or kidney dysfunction
- Refusal to participate in the clinical study
- History of allergy to any component of the imaging agent or allergic constitution
- Childbearing-aged males or females unable to use effective contraception
- Women planning pregnancy, currently pregnant, 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
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
Research Team
G
guang Zhen Wang
CONTACT
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
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