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Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2026 to Dec 31, 2026
    • Study completion date: Dec 1, 2027 to Dec 31, 2027
    • Start date changed from estimate of Dec 1, 2023 to Nov 23, 2023
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective cohort clinical research that analyzes the changes in CMR parameters before and after immune checkpoint inhibitors (ICIs) therapy in patients with gynecologic malignancies. It also evaluates the value of CMR parameters in predicting long-term outcomes. The baseline assessment will be conducted prior to ICIs treatment, followed by multiple assessments during the medication process including within one week prior to cycle 3 , within the week prior to cycle 5 , 1 year after the first dose, and 2 years after the first dose. Assessment will also be conducted after discontinuation of ICIs medication. The assessment includes clinical assessment, CMR imaging, echocardiography, serum cardiac injury biomarkers, etc. Cancer therapy-related cardiac dysfunction (CTRCD), survival, and major adverse cardiac events (MACE) will be followed up.
Trial Details
NCT Number NCT06132984
Lead Sponsor West China Second University Hospital
Conditions
(from sponsor)		 Immune Checkpoint Inhibitors, Cardiotoxicity
Related terms Cardiotoxicity
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov