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Trial Title:
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity
NCT ID:
NCT06132984
Condition:
Immune Checkpoint Inhibitors, Cardiotoxicity
Conditions: Official terms:
Cardiotoxicity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Cardiac magnetic resonance
Description:
Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and
T2-mapping.
Arm group label:
Patients with gynecologic malignancies who are preparing for ICIs treatment
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.
Criteria for eligibility:
Study pop:
Patients with gynecologic malignancies who are preparing for ICIs treatment
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
West China Second University Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Ye, Assoc Prof
Phone:
86-028-88570418
Email:
cltwo@163.com
Investigator:
Last name:
Ying-kun Guo, Prof
Email:
Principal Investigator
Start date:
November 23, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
West China Second University Hospital
Agency class:
Other
Source:
West China Second University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132984
