Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

Recruiting

• Conditions: Immune Checkpoint Inhibitors, Cardiotoxicity
• Interventions: Diagnostic Test: Cardiac magnetic resonance

• Registration Number: NCT06132984
• Lead Sponsor: West China Second University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-15
• Study Start: 2023-11-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-18
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• 1. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
• 2. Patients who are preparing for monotherapy or combination therapy with ICIs.
• 3. Voluntary signing of informed consent form.
• 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• 5. Expected survival of at least 6 months.

Exclusion Criteria

• 1. Previously received ICIs treatment.
• 2. With allergies or contraindications to ICIs.
• 3. Confirmed to be brain metastasis.
• 4. Patients who have major surgery within 4 weeks prior to or following the screening period.

• 5. 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:

  6. the use of topical or inhaled corticosteroids is permitted;

  7. short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.

• 6. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
• 7. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
• 8. Lack of autonomous capacity, or a documented history of mental disease.
• 9. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with gynecologic malignancies who are preparing for ICIs treatment	Cardiac magnetic resonance	-

Primary Outcome Measures

Name	Time	Method
cancer therapy-related cardiac dysfunction (CTRCD)	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 Outcome Measures

Name	Time	Method
All-cause death; major adverse cardiac events (MACE)	2 month to 3 years	MACE were defined as a composite of cardiovascular death, cardiac arrest,cardiogenic shock, myocarditis, acute coronary syndromes (including non-ST-segment elevation and ST-segment elevation myocardial infarction), congestive heart failure, nonmalignant pericardial disorders, dysrhythmias（including complete heart block，documented sustained ventricular tachycardia, ventricular fibrillation)

Trial Locations

Locations (1)

West China Second University Hospital; 🇨🇳 Chengdu, Sichuan, China