Actively Recruiting
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
Led by West China Second University Hospital · Updated on 2025-08-01
22
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
- Patients preparing for monotherapy or combination therapy with immune checkpoint inhibitors.
- Voluntarily signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of at least 6 months.
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors.
- Allergies or contraindications to immune checkpoint inhibitors.
- Confirmed brain metastasis.
- Major surgery within 4 weeks before or after screening.
- Use of systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs within 14 days before enrollment or during the study, except topical or inhaled corticosteroids and short-term use (≤7 days) for non-autoimmune diseases.
- Left ventricular ejection fraction ≤50% or New York Heart Association functional class III or higher.
- Diagnosed coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease, or pericardial diseases.
- Lack of autonomous capacity or history of mental disease.
- MRI contraindications including pacemakers, neurostimulators, metallic implants or foreign bodies, severe hyperthermia, claustrophobia, or severe respiratory conditions preventing breath-holding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Second University Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
L
Lu Ye
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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