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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from The Affiliated Hospital of Qingdao University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 2026 to Dec 2027 Show 6 more changesShow less
    • Enrollment increased: 40 → 120 participants
    • Interventions: 18F-NY104 PET/CT (Radiation) to 18F-NY104 PET/CT (Radiation)
    • Eligibility criteria expanded, about 38 words
    • Study description expanded, about 9 words
    • Collaborators revised (4)
    • Publications: details revised at 1 of 1 entry
  2. Minor Start date changed from estimate of Apr 2025 to Apr 12, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06916624
Lead Sponsor The Affiliated Hospital of Qingdao University
Collaborators: Qianfoshan Hospital, Weifang People's Hospital, Zibo Central Hospital, Affiliated Hospital of Jining Medical University
Conditions
(from sponsor)
Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma (ccRCC)
Related terms Carcinoma, Renal Cell
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov