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NCT Number: NCT06132984

Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location status: Recruiting

Location contact

Lu Ye, Assoc Prof

CONTACT

[email protected]

86-028-88570418

Ying-kun Guo, Prof

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.

Treatment and study plan

Cardiac magnetic resonance

Diagnostic Test

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

Primary outcomes

  1. 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

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 15, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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