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: 40
• Locations: 1 country
• Sites: 1

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 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

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

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 either clinically diagnosed with or suspected to have clear cell renal cell carcinoma (ccRCC), or those with suspected post-treatment recurrence or metastasis of ccRCC.

You may qualify if:

• (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.

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
• Jining Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

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, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)