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

ConditionsRenal Cell Carcinoma (RCC)Clear Cell Renal Cell Carcinoma (ccRCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 18F-NY104 PET/CT scan1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Hospital of Qingdao University

Lead sponsor

Qianfoshan Hospital

Collaborator

Weifang People's Hospital

Collaborator

Zibo Central Hospital

Collaborator

Jining Medical University

Collaborator

Source ClinicalTrials.gov
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