Clincosm LogoSign in Get a demo

Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

Sponsor
West China Second University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06132984
Collaborator
(none)
22
Enrollment
48
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cardiac magnetic resonance

Study Design

Study Type:
Observational
Anticipated Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity in Patients With Gynecologic Malignancies: A Cohort Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Patients with gynecologic malignancies who are preparing for ICIs treatment

Diagnostic Test: Cardiac magnetic resonance
Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and T2-mapping.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
    1. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
    1. Patients who are preparing for monotherapy or combination therapy with ICIs.
    1. Voluntary signing of informed consent form.
    1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    1. Expected survival of at least 6 months.
Exclusion Criteria:
    1. Previously received ICIs treatment.
    1. With allergies or contraindications to ICIs.
    1. Confirmed to be brain metastasis.
    1. Patients who have major surgery within 4 weeks prior to or following the screening period.
    1. 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:

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

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

    1. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
    1. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
    1. Lack of autonomous capacity, or a documented history of mental disease.
    1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • West China Second University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ying-kun Guo, Professor, West China Second University Hospital
ClinicalTrials.gov Identifier:
NCT06132984
Other Study ID Numbers:
  • WestChinaSUH2022228
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiotoxicity

Study Results

No Results Posted as of Nov 15, 2023