Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 13 for:    PREFECT

MyoStrain CMR for the Detection of Cardiotoxicity (Prefect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543228
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Myocardial Solutions

Brief Summary:
The Prefect Pilot Study evaluates the use of the EC approved MyoStrain SENC CMR Imaging System to detect cardiotoxicity from drugs used to treat cancer (e.g. Breast Cancer and Lymphomas).

Condition or disease Intervention/treatment
Cardiotoxicity Heart Failure Chemotherapeutic Toxicity Diagnostic Test: MyoStrain

Detailed Description:

The study is a prospective, observational, single center, observational clinical study that will enroll up to 50 patients undergoing chemotherapy and/or targeted therapy with or without concomitant radiotherapy for the treatment of breast cancer or lymphoma. Enrolled subjects will be evaluated with the MyoStrain SENC CMR Imaging System that measures myocardial strain during standard Cardiac Magnetic Resonance imaging at baseline through 6 month follow-up.

The MyoStrain SENC CMR Imaging System has been approved with an EC Certificate according to Directive 93/42/EEC on Medical Devices, Annex II excluding Section 4 (CE 657862) in respect of: Design, development and manufacture of software for the quantification of cardiac MRI images. MyoStrain measures the contraction of heart muscle in one heartbeat per image plane. With 6 image planes (3 short axis & 3 long axis), a complete measure of the health of the myocardium, both regionally and globally, can be obtained within a minute without requiring contrast injection or a breath-hold.

Heart health will be monitored throughout cancer therapy to quantify the toxic effects of chemotherapy with or without a reduction in traditional measures such as ejection fraction, and the ability to reverse observed cardiotoxicity with standard heart failure therapy.

The goal of the study is to determine the ability to detect subclinical cardiotoxicity before extensive damage causes the reduction in traditional measures, which are currently used to categorize heart failure and serve as the basis of treatment guidelines.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
MyoStrain
During standard chemotherapy and/or targeted treatment for breast cancer or lymphoma, MyoStrain will be used during standard cardiac magnetic resonance imaging to evaluate the change in myocardial contraction regionally and globally to detect cardiotoxicity and management of myocardial dysfunction.
Diagnostic Test: MyoStrain
MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.




Primary Outcome Measures :
  1. Accuracy of MyoStrain to Detect Cardiotoxicity [ Time Frame: 6 months ]
    Sensitivity of MyoStrain CMR Software to quantify myocardial dysfunction before changes in traditional measures including ejection fraction as ascertained by Biomarkers including BNP, Troponin, and SF-36 Quality of Life. Sensitivity will be calculated by looking at paired t-test evaluations comparing follow-up time points to baseline as to whether changes associated with administration of chemotherapy agents and/or heart failure therapy are detected.


Secondary Outcome Measures :
  1. Cardiotoxicity Incidence of Chemotherapy Drugs [ Time Frame: 6 months ]
    Incidence of subclinical dysfunction during chemotherapy as determined by CMR detection of the amount and locations of declining segmental myocardial contraction with MyoStrain software that measured the ability of the myocardium to contract in 37 segments of the heart (16 longitudinal strain measurements from 3 short axis planes & 21 circumferential strain segments from 3 long-axis planes).

  2. Efficacy of Heart Failure Therapy to Treat Cardiotoxicity [ Time Frame: 6 months ]
    Impact of heart failure medications to improve subclinical dysfunction, calculated by improvement in previously worsened segmental myocardial contraction with MyoStrain software that measured the ability of the myocardium to contract in 37 segments of the heart (16 longitudinal strain measurements from 3 short axis planes & 21 circumferential strain segments from 3 long-axis planes).

  3. Cardiotoxicity Risk Stratification [ Time Frame: 6 months ]
    Ability to detect risk of developing cardiotoxicity by quantifying subclinical myocardial dysfunction in patients with segmental strain at baseline exceeding predefined thresholds. Higher risk patients will be defined as 2 or more segments > -10% with MyoStrain measurements OR 9 or more segments > -17%; Lower risk patients will be the remaining patients. The changes in strain for each patient category will be evaluated by changes in segmental strain during oncology therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be carefully selected from the pool of patients currently undergoing or scheduled to undergo chemotherapy for cancer treatment including breast cancer and lymphoma patients.
Criteria

Inclusion Criteria:

  • Undergoing Chemotherapy for Cancer Treatment
  • Provided Written Informed Consent

Exclusion Criteria:

  • Contraindication to Magnetic Resonance Imaging
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543228


Locations
Layout table for location information
Germany
Marien Krankenhaus GmbH
Hamburg, Germany, 22087
Sponsors and Collaborators
Myocardial Solutions
Investigators
Layout table for investigator information
Principal Investigator: Henning Steen, MD Marien Krankenhaus
Layout table for additonal information
Responsible Party: Myocardial Solutions
ClinicalTrials.gov Identifier: NCT03543228    
Other Study ID Numbers: VAL-1005P(A)
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Myocardial Solutions:
Strain
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries