PhysioFlow to Detect Cardiotoxicity in Chemo | NCT02220569

Studies
PhysioFlow to Detect Cardiotoxicity in Chemo

NCT02220569

Sponsor

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

Status

Unknown status

Last Update Posted

Sep 23, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Chemotherapy, Cancer, Cardiotoxicity, Physioflow

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Aug 14, 2014

First Submission Date that Met QC Criteria

Aug 18, 2014

First Posted Date

Aug 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nathaniel Bouganim, Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparing the change in ejection fraction measured by physioflow and MUGA scan		at initial diagnosis and after 3 month

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 18 years old
Histologically confirmed diagnosis of cancer
ECOG 0 to 2
Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
Able to adhere to the study visit schedule and other protocol requirements

Control Group

Age above 18 years old
No previous history of cancer
ECOG 0 to 2
Did not receive chemotherapeutic agents (even if outside the context of cancer)
Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained
Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

Age less than 18 years
ECOG 3-4
Suspected or proven severe aortic insufficiency
Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting device)
Congenital cardiac deformities ,such as septal defects
Refuse to comply with the specified visit schedules and requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving chemotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ralph Maroun, M.D.	Contact	5147080701		ralph.maroun@mail.mcgill.ca

Overall Officials

Name	Affiliation	Role
Nathaniel Bouganim, MD	McGill University Health Centre/Research Institute of the McGill University Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill university health center, Royal Victoria hospital	Not yet recruiting	Montreal	Quebec	h3a 1a1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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