Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

July 29, 2025 updated by: Ying-kun Guo, West China Second University Hospital

Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity in Patients With Gynecologic Malignancies: A Cohort Study

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Second University Hospital
        • Contact:
          • Lu Ye, Assoc Prof
          • Phone Number: 86-028-88570418
          • Email: cltwo@163.com
        • Principal Investigator:
          • Ying-kun Guo, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with gynecologic malignancies who are preparing for ICIs treatment

Description

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:

    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.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 month to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death; major adverse cardiac events (MACE)
Time Frame: 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)
2 month to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Second University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaSUH2022228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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