MyoStrain CMR for the Detection of Cardiotoxicity
Prefect
Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity
1 other identifier
observational
63
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedJune 25, 2021
June 1, 2021
2.5 years
May 17, 2018
June 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy of MyoStrain to Detect Cardiotoxicity
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.
6 months
Secondary Outcomes (3)
Cardiotoxicity Incidence of Chemotherapy Drugs
6 months
Efficacy of Heart Failure Therapy to Treat Cardiotoxicity
6 months
Cardiotoxicity Risk Stratification
6 months
Study Arms (1)
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.
Interventions
MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.
Eligibility Criteria
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.
You may qualify if:
- Undergoing Chemotherapy for Cancer Treatment
- Provided Written Informed Consent
You may not qualify if:
- Contraindication to Magnetic Resonance Imaging
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marien Krankenhaus GmbH
Hamburg, 22087, Germany
Related Publications (1)
Giusca S, Korosoglou G, Montenbruck M, Gersak B, Schwarz AK, Esch S, Kelle S, Wulfing P, Dent S, Lenihan D, Steen H. Multiparametric Early Detection and Prediction of Cardiotoxicity Using Myocardial Strain, T1 and T2 Mapping, and Biochemical Markers: A Longitudinal Cardiac Resonance Imaging Study During 2 Years of Follow-Up. Circ Cardiovasc Imaging. 2021 Jun;14(6):e012459. doi: 10.1161/CIRCIMAGING.121.012459. Epub 2021 Jun 15.
PMID: 34126756RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Steen, MD
Marien Krankenhaus
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
June 1, 2018
Study Start
August 1, 2017
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
June 25, 2021
Record last verified: 2021-06