Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04861532
Status:
UNKNOWN
Last Update Posted:
2021-06-10
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Protocols and Methods for Image Processing and Enhancement of MRI Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image Signal to Noise Ratio (SNR)', 'timeFrame': 'Through study completion, an average of 2 months.', 'description': "Comparing the SNR of images obtained by conventional protocols with the corresponding New Protocols' processed images. The comparison will be performed by neuroradiologists, using a 7-point Likert-scale. Where higher the score, better the outcome (1 means unacceptable and 7 means excellent)."}, {'measure': 'Image Resolution', 'timeFrame': 'Through study completion, an average of 2 months.', 'description': "Comparing the resolution of images obtained by conventional protocols with the corresponding New Protocols' processed images. The comparison will be performed by neuroradiologists, using a 7-point Likert-scale. Where higher the score, better the outcome (1 means unacceptable and 7 means excellent)."}, {'measure': 'Artifacts', 'timeFrame': 'Through study completion, an average of 2 months.', 'description': "Comparing artifacts of images obtained by conventional protocols with the corresponding New Protocols' processed images. The comparison will be performed by neuroradiologists, using a 7-point Likert-scale. Where higher the score, better the outcome (1 means unacceptable and 7 means excellent)."}, {'measure': 'MRI contrast', 'timeFrame': 'Through study completion, an average of 2 months.', 'description': "Comparing MR contrast of images obtained by conventional protocols with the corresponding New Protocols' processed images. The comparison will be performed by neuroradiologists, using a 7-point Likert-scale. Where higher the score, better the outcome (1 means unacceptable and 7 means excellent)."}, {'measure': 'Diagnostic quality', 'timeFrame': 'Through study completion, an average of 2 months.', 'description': "Comparing diagnostic quality of images obtained by conventional protocols with the corresponding New Protocols' processed images. The comparison will be performed by neuroradiologists, using a 7-point Likert-scale. Where higher the score, better the outcome (1 means unacceptable and 7 means excellent)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['MRI Image Enhancement']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop new Magnetic Resonance Imaging (MRI) protocols and methods for image processing and enhancement. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols". Then post-processing will be applied on new protocols to enhance the image quality. Finally a comparison of image quality will be performed to compare the image quality of images obtained by conventional protocols with those obtained with the New Protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Total number of subjects expected to participate in this study is up to 100. This study will be performed at multiple sites and data will be collected from different MRI scanners of variable field strength using several MRI protocols. To provide sufficient statistical power for the investigation of each subgroup, we need a large sample size.\n\nChildren, pregnant women and prisoners that are considered vulnerable population by federal regulation will not be included in this study. In addition, decisional incapacity subject will be excluded.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers for clinical MRI examination\n* Patients undergoing clinical MRI examination\n* Capable to provide an informed written consent form\n\nExclusion Criteria:\n\n* Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).\n* Age \\<18 years old\n* Pregnancy\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT04861532', 'briefTitle': 'Development of Protocols and Methods for Image Processing and Enhancement of MRI Data', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Development of Protocols and Methods for Image Processing and Enhancement of MRI Data', 'orgStudyIdInfo': {'id': '0106-16-HYMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI scanning using new protocols'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OTHER', 'city': 'Hadera', 'state': 'Select One', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Libi Mori', 'role': 'CONTACT', 'email': 'LIBI@MEDICVISION.COM'}], 'facility': 'Hillel Yaffe', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Libi Mori', 'role': 'CONTACT', 'email': 'LIBI@MEDICVISION.COM', 'phone': '+972.73.726.2226'}], 'overallOfficials': [{'name': 'Libi Mori', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medic Vision Imaging Solutions Ltd'}, {'name': 'Roni Shreter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Medic Vision Imaging Solutions', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}