Monitoring heart health in patients receiving immune checkpoint inhibitors for gynecologic cancers

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

This study is looking at how immune checkpoint inhibitors affect heart health in women with gynecologic cancers by checking their heart function before and after treatment.

Quick facts

• Study type: Observational
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: West China Second University Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06132984 on ClinicalTrials.gov

What this trial studies

This observational study follows female patients aged 18 to 75 with gynecologic malignancies who are starting treatment with immune checkpoint inhibitors (ICIs). It involves a prospective cohort design where cardiac magnetic resonance (CMR) imaging and other assessments are conducted before and after the initiation of ICIs therapy. The study aims to evaluate changes in cardiac function and predict long-term outcomes related to cardiotoxicity. Multiple assessments will occur throughout the treatment process and during follow-up to monitor cardiac health and potential adverse events.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with a diagnosis of gynecologic malignancies who are about to start ICIs treatment.

Not a fit: Patients who have previously received ICIs treatment or have contraindications to ICIs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify cardiac risks associated with ICIs, leading to better management of heart health in cancer patients.

How similar studies have performed: While there is ongoing research into cardiotoxicity related to cancer therapies, this specific approach using CMR monitoring in this patient population is relatively novel.

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.

Where this trial is running

Chengdu, Sichuan

• West China Second University Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Lu Ye

Conditions Immune Checkpoint Inhibitors, Cardiotoxicity