PhysioFlow to Detect Cardiotoxicity in Chemo

N/AUnknownNCT02220569

McGill University Health Centre/Research Institute of the McGill University Health Centre100 enrolled

Overview

PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving chemotherapy early on in order to avoid irreversible damage. In addition to that, we will test if the PhysioFlow is non-inferior to the conventional MUGA scan.

Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are statistically the same using both techniques. This is what is known as a non-inferior study. The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or while the patient is receiving his or her chemotherapy. The patient will be tested with the MUGA scan, as per the standard of care, before chemotherapy is initiated and at every 3 months. The patient will also be tested with the PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be tested at each chemotherapy cycle with the PhysioFlow. Should the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving chemotherapy, the results will be confirmed with the MUGA scan.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age above 18 years old 2. Histologically confirmed diagnosis of cancer 3. ECOG 0 to 2 4. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 5. Able to adhere to the study visit schedule and other protocol requirements Control Group 1. Age above 18 years old 2. No previous history of cancer 3. ECOG 0 to 2 4. Did not receive chemotherapeutic agents (even if outside the context of cancer) 5. Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained 6. Able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: 1. Age less than 18 years 2. ECOG 3-4 3. Suspected or proven severe aortic insufficiency 4. Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device) 5. Congenital cardiac deformities ,such as septal defects 6. Refuse to comply with the specified visit schedules and requirements

Locations (2)

McGill university health center, Royal Victoria hospital

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Royal Victoria Hospital

Montreal, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

comparing the change in ejection fraction measured by physioflow and MUGA scan

Time frame: at initial diagnosis and after 3 month

Secondary Outcomes

acceptance score on the five-point Likert Scale to measure tolerability

At the end of physioflow and or MUGA scan, a questionnaire to assess acceptance was proposed to all patients. The following aspects were evaluated: preparation and information before the imaging examination, degree of preceding concern, comfort, helplessness during the examination, pain experienced, degree of overall satisfaction. Evaluation was performed with a five-point qualitative Likert scale: very low, low, moderate, high, very high

Time frame: up to 24 hrs

Central Contacts

Ralph Maroun, M.D.

CONTACT

5147080701 ralph.maroun@mail.mcgill.ca

Data from ClinicalTrials.gov

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