Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 3:22 PM
Study NCT ID:
NCT03543228
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyoStrain CMR for the Detection of Cardiotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of MyoStrain to Detect Cardiotoxicity', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cardiotoxicity Incidence of Chemotherapy Drugs', 'timeFrame': '6 months', 'description': '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).'}, {'measure': 'Efficacy of Heart Failure Therapy to Treat Cardiotoxicity', 'timeFrame': '6 months', 'description': '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).'}, {'measure': 'Cardiotoxicity Risk Stratification', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Strain'], 'conditions': ['Cardiotoxicity', 'Heart Failure', 'Chemotherapeutic Toxicity']}, 'referencesModule': {'references': [{'pmid': '34126756', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nThe 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.\n\nHeart 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing Chemotherapy for Cancer Treatment\n* Provided Written Informed Consent\n\nExclusion Criteria:\n\n* Contraindication to Magnetic Resonance Imaging\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03543228', 'acronym': 'Prefect', 'briefTitle': 'MyoStrain CMR for the Detection of Cardiotoxicity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myocardial Solutions'}, 'officialTitle': 'Prefect Study of MyoStrain CMR for the Detection of Cardiotoxicity', 'orgStudyIdInfo': {'id': 'VAL-1005P(A)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MyoStrain', 'description': '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.', 'interventionNames': ['Diagnostic Test: MyoStrain']}], 'interventions': [{'name': 'MyoStrain', 'type': 'DIAGNOSTIC_TEST', 'description': 'MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.', 'armGroupLabels': ['MyoStrain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22087', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Marien Krankenhaus GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Henning Steen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marien Krankenhaus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myocardial Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}