Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorWest China Second University Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cardiac magnetic resonance
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov