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Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast Cancer, Lymphoma or Leukemia

NCT04541212

Active Not RecruitingN/A

Sponsor: Montreal Heart Institute

Conditions: Breast Cancer, Lymphoma, Leukemia

Interventions: Cardiac Imaging, Data Collection

Countries: Canada

This is an observational study of the occurrence of cardiac toxicity in patients with breast cancer,lymphoma or leukemia receiving chemotherapy including an anthracycline. Patients will be identified at the oncology clinic and will be included in the study if all eligible criteria are met. The study will involve retrospective and prospective evaluations. Safety will be assessed through reporting of serious adverse events (SAEs) related to study procedures.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Study type: OBSERVATIONAL

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

Locations (6)

Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Terrebonne, Quebec (QC), Canada