Status:
RECRUITING
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
Lead Sponsor:
West China Second University Hospital
Conditions:
Immune Checkpoint Inhibitors, Cardiotoxicity
Eligibility:
FEMALE
18-75 years
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06132984
Start Date
November 23 2023
End Date
December 31 2027
Last Update
August 1 2025
Active Locations (1)
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1
West China Second University Hospital
Chengdu, Sichuan, China, 610041