Status:
RECRUITING
Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Qianfoshan Hospital
Weifang People's Hospital
Conditions:
Renal Cell Carcinoma (RCC)
Clear Cell Renal Cell Carcinoma (ccRCC)
Eligibility:
All Genders
18-75 years
Brief Summary
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 car...
Detailed Description
Currently, the global population with kidney diseases exceeds 500 million, and the number of kidney disease patients in China is approximately 120 million, accounting for about 10.8% of the adult popu...
Eligibility Criteria
Inclusion
- (1)Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements; (2)Age 18-75 years; no gender restrictions; (3)Clinically diagnosed/suspected as renal cell carcinoma or clinically diagnosed/suspected recurrence/metastasis after RCC treatment; (4)At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1); (5)ECOG performance status score of 0-2; (6)Laboratory parameters must meet:
- Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L; PT or APTT ≤1.5×ULN (upper limit of normal);
- Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;
- Other routine tests within normal ranges or deemed acceptable by the investigator; (7)Expected survival ≥12 weeks; (8) Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.
Exclusion
- Recovery from major trauma (including surgery) within 4 weeks prior to study examination;
- Patients with systemic or local severe infections or other serious comorbidities;
- Severe hepatic or renal dysfunction;
- Refusal to participate in this clinical study;
- Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;
- Childbearing-aged male or female subjects who cannot adopt effective contraception;
- Women planning pregnancy, currently pregnant, or lactating;
- Patients unable or unwilling to undergo PET/CT scanning;
- Other subjects deemed ineligible by the investigator.
Key Trial Info
Start Date :
April 12 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06916624
Start Date
April 12 2025
End Date
December 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China