Using 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 renal cell carcinoma, clinically diagnosed/suspected recurrence and/or metastasis after treatment of renal cell carcinoma, or CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma;
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 ≥90 g/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 is 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.