NCT06132984 Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
| NCT ID | NCT06132984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | West China Second University Hospital |
| Condition | Immune Checkpoint Inhibitors, Cardiotoxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 22 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 22 participants in total. It began in 2023-11-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06132984 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Immune Checkpoint Inhibitors, Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06132984 currently recruiting?
Yes, NCT06132984 is actively recruiting participants. Contact the research team at cltwo@163.com for enrollment information.
Where is the NCT06132984 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06132984 clinical trial?
NCT06132984 is sponsored by West China Second University Hospital. The trial plans to enroll 22 participants.