Clinical trial NCT03543228: MyoStrain CMR for the Detection of Cardiotoxicity
Official title: Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiotoxicity
Heart Failure
Chemotherapeutic Toxicity
Keywords: Strain
Lead sponsor: Myocardial Solutions
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: Inclusion Criteria:

* Undergoing Chemotherapy for Cancer Treatment
* Provided Written Informed Consent

Exclusion Criteria:

* Contraindication to Magnetic Resonance Imaging
* Pregnancy

Primary outcomes:
measure: Accuracy of MyoStrain to Detect Cardiotoxicity
timeFrame: 6 months
Secondary outcomes:
measure: Cardiotoxicity Incidence of Chemotherapy Drugs
timeFrame: 6 months
measure: Efficacy of Heart Failure Therapy to Treat Cardiotoxicity
timeFrame: 6 months
measure: Cardiotoxicity Risk Stratification
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Marien Krankenhaus GmbH
Study officials:
affiliation: Marien Krankenhaus
name: Henning Steen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.