Clinical Trial: PhysioFlow to Detect Cardiotoxicity in Chemo

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: McGill University Health Center

Current Primary Outcome: comparing the change in ejection fraction measured by physioflow and MUGA scan [ Time Frame: at initial diagnosis and after 3 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: acceptance score on the five-point Likert Scale to measure tolerability [ Time Frame: up to 24 hrs ]

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


Original Secondary Outcome: Same as current

Information By: McGill University Health Center

Dates:
Date Received: August 14, 2014
Date Started: October 2014
Date Completion: July 2016
Last Updated: September 21, 2015
Last Verified: September 2015