Using 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma
This study is testing a new imaging method using a special dye to see if it can help doctors better diagnose kidney cancer and understand how a low-dose medication affects the images in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT06916624 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 18F-NY104 PET/CT imaging in diagnosing renal cell carcinoma (RCC), including its sensitivity, specificity, and accuracy in identifying primary, recurrent, and metastatic lesions. Additionally, it investigates how a low-dose CAIX inhibitor, Acetazolamide, affects the distribution of 18F-NY104 in the kidneys and stomach of RCC patients. The study aims to improve diagnostic methods for RCC, which is increasingly prevalent and aggressive. Participants will undergo imaging to assess the performance of this novel diagnostic approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with clinically diagnosed or suspected renal cell carcinoma or its recurrence/metastasis.
Not a fit: Patients with no measurable solid lesions or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of RCC diagnosis and improve patient management strategies.
How similar studies have performed: While similar imaging techniques have been explored, the specific use of 18F-NY104 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (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: 1. 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); 2. 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; 3. 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 Criteria: 1. Recovery from major trauma (including surgery) within 4 weeks prior to study examination; 2. Patients with systemic or local severe infections or other serious comorbidities; 3. Severe hepatic or renal dysfunction; 4. Refusal to participate in this clinical study; 5. Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution; 6. Childbearing-aged male or female subjects who cannot adopt effective contraception; 7. Women planning pregnancy, currently pregnant, or lactating; 8. Patients unable or unwilling to undergo PET/CT scanning; 9. Other subjects deemed ineligible by the investigator.
Where this trial is running
Qingdao, Shandong
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
Study contacts
- Study coordinator: guang Zhen Wang
- Email: wangzhenguang@qde.edu.cn
- Phone: ＋86-0532-82913318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.