Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT04541212
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older at time of CT initiation
* Signed informed consent
* Patients with diagnosis of breast cancer,lymphoma or leukemia (including autografted subjects)
* Planned, ongoing or completed (within last 5 years) chemotherapy with anthracycline
* Left ventricular ejection fraction (LVEF) ≥50% pre-chemotherapy
* The participant is willing to undergo CMR scans and all other required study procedures
Exclusion Criteria:
* Known cardiomyopathy and/or LVEF \<50%
* Known heart failure
* History of myocardial infarction (MI)
* Clinically significant cardiac valvular disease
* Clinically significant pericardial effusion
* Allografted subjects
* Contraindications to CMR testing (Cohort A \& prospective evaluation for Cohort B):
* Pacemakers, other metallic implants or severe claustrophobia
* Weight \> 135 kg
* Patients with a history of previous allergic reaction to gadolinium
* Patients with history of seizure
* Renal insufficiency (eGFR of \< 45ml/min/1.73m2 using the MDRD equation)
* Pregnant or breastfeeding women
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04541212
Study Brief:
Protocol Section:
NCT04541212