Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma

NCT06916624 | Recruiting

• 1 other identifier: QDFY-NM-25003
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in detecting primary, recurrent, and metastatic lesions of renal cell carcinoma (RCC), and to explore its potential for imaging and treatment response assessment in other CAIX-positive solid tumors, such as breast cancer and nasopharyngeal carcinoma, where high CAIX expression is associated with poor prognosis. The study will also investigate the effect of oral low-dose acetazolamide on the biodistribution of 18F-NY104, particularly in the stomach and kidneys.

Conditions

Clear Cell Renal Cell Carcinoma (ccRCC); Renal Cell Carcinoma (RCC)

Outcome Measures

Primary Outcomes (1)

• SUV

  The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

  2 years

Study Arms (1)

18F-NY104 PET/CT scan

Radiation: 18F-NY104 PET/CT

Interventions

18F-NY104 PET/CT RADIATION

The radionuclide ¹⁸F will serve as the tracer in this study. NY104 will be labeled with \[¹⁸F\]AlF to form the ¹⁸F-NY104 injection for use in this research.All participants will undergo ¹⁸F-NY104 PET scan.

18F-NY104 PET/CT scan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort primarily included patients who were clinically diagnosed with or suspected to have renal cell carcinoma (RCC), those with suspected recurrence or metastasis after treatment of RCC, and patients with CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma.

You may qualify if:

• Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements;
• Age 18-75 years; no gender restrictions;
• 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;
• At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1);
• ECOG performance status score of 0-2;
• Laboratory parameters must meet:
• 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);
• 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;
• Other routine tests: Within normal ranges or deemed acceptable by the investigator;
• Expected survival ≥12 weeks;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Qianfoshan Hospital: collaborator
• Weifang People's Hospital: collaborator
• Zibo Central Hospital: collaborator
• Affiliated Hospital of Jining Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Related Publications (1)

• Nie P, Li B, Luo L, Hou F, Zhang N, Yang H, Huang X, Zhu Z, Ma S, Wu T, Xie J, Zhang M, Yang G, Wang Z. A prospective head-to-head comparison of 18F-NYM005 PET/CT and 18F-FDG PET/CT in diagnosing renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2026 Jul;53(8):5002-5012. doi: 10.1007/s00259-026-07841-2. Epub 2026 Mar 20.

  PMID: 41857358 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

guang Zhen Wang

CONTACT

＋86-0532-82913318; wangzhenguang@qde.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)