Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity in Patients With Gynecologic Malignancies: A Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- cancer therapy-related cardiac dysfunction (CTRCD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
- •Patients who are preparing for monotherapy or combination therapy with ICIs.
- •Voluntary signing of informed consent form.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected survival of at least 6 months.
Exclusion Criteria
- •Previously received ICIs treatment.
- •With allergies or contraindications to ICIs.
- •Confirmed to be brain metastasis.
- •Patients who have major surgery within 4 weeks prior to or following the screening period.
- •Patients who have received systemic corticosteroids (at a dose equivalent to >10 mg prednisone per day) or other immunosuppressive medications within 14 days prior to enrollment or during the study period; however, the following situations are allowed for inclusion:
- •the use of topical or inhaled corticosteroids is permitted;
- •short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.
- •Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
- •Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
- •Lack of autonomous capacity, or a documented history of mental disease.
- •MRI contraindications: Pacemakers, neurostimulators, artificial metal heart valves, arterial aneurysm clips, intraocular metallic foreign bodies, inner ear implants, metal prostheses, metal limbs, metal joints, and any other metallic implants or foreign objects; severe hyperthermia patients; claustrophobia; severe respiratory conditions that prevent breath-holding.
Outcomes
Primary Outcomes
cancer therapy-related cardiac dysfunction (CTRCD)
Time Frame: 2 month to 3 years
Any reduction of LVEF to below 50% or a \>10% reduction from baseline falling below the lower limit of normal.
Secondary Outcomes
- All-cause death; major adverse cardiac events (MACE)(2 month to 3 years)
Investigators
Ying-kun Guo
Professor
West China Second University Hospital