Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT03567018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2018-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-13', 'size': 296447, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-05-18T12:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two populations are being investigated in this trial; a healthy volunteer population and a patient population. Each population will receive an MRI scan.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'image quality', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}, {'measure': 'Artifacts in MRI images assessed by experienced readers', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}, {'measure': 'Vessel detectability in MRI assessed by experienced readers', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed by blinded readers'}, {'measure': 'Image noise as a measure of image quality assessed by quantitative measures', 'timeFrame': 'through study completion, on average 2-5 years', 'description': 'assessed region of interest over target tissue and background'}], 'secondaryOutcomes': [{'measure': 'Anatomy accuracy', 'timeFrame': '60 min', 'description': 'Location on images'}, {'measure': 'Vascular network continuity', 'timeFrame': '60 min', 'description': 'Location on images'}, {'measure': 'Perforator branching pattern', 'timeFrame': '60 min', 'description': 'Location on images'}, {'measure': 'Potential Clinical Use of the MRI Images for Clinical Decision making', 'timeFrame': 'Baseline', 'description': 'Clinical reader assessment'}, {'measure': 'Signal-to-noise ratio (SNR)', 'timeFrame': 'Baseline', 'description': 'ROI based assessment'}, {'measure': 'Contrast-to-noise ratio (CNR) to muscle and fat', 'timeFrame': 'Baseline', 'description': 'ROI based assessment'}, {'measure': 'Perforator size', 'timeFrame': '60 min', 'description': 'Location on images'}, {'measure': 'Length of perforator intramuscular course', 'timeFrame': '60 min', 'description': 'Location on images'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Perforator Flap Surgery']}, 'descriptionModule': {'briefSummary': "In this study the investigators plan to enroll a total of 25 evaluable volunteers (volunteer population) for the development and optimization of perforator imaging protocols and 50 evaluable clinical patients receiving flap procedures at OSUMC for the clinical validation of the optimized protocol. No extrinsic MR contrast agent will be injected. Clinical patients' MRI images will be evaluated independently by radiologists and plastic surgeons and compared to the clinical CTA images.", 'detailedDescription': 'The overall objective of this pilot study is to develop and optimize preoperative MRA imaging protocols for various perforators commonly used in flap surgery with phantoms and healthy volunteers and to obtain clinical validation of the optimized protocols with a group of patients receiving flap surgery at The OSU Wexmer Medical Center. Data obtained in this study may also serve as the basis for statistical planning of future clinical trials. Based on previous experience with other magnetic resonance imaging (MRI) techniques, the investigators hypothesize that optimal MRA images can only be obtained with a carefully selected combination of imaging hardware, acquisition, and postprocessing factors. The main objective of this pilot study is to determine this optimal combination through the comparison of image between different combinations. The secondary objective of this pilot study is to evaluate, both qualitatively and quantitatively, the quality of the optimized MRA images and compare them with clinical CTA images. The primary hypothesis is that the quality of the optimized MRA images is at least comparable to that of the CTA images. The quantitative measurements obtained from this pilot population will also serve as the preliminary data for future studies and be used in statistical calculations that determine their study population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than or equal to 18 years at time of enrollment\n* able to provide informed consent\n* able to lie in both prone and supine positions for at least 30 minutes\n* the clinical patients need to have a flap procedure scheduled at the Ohio State University Medical Center within the next 24 months\n\nExclusion Criteria:\n\n* Use of an IUD (intrauterine device) or medical patch\n* Subjects with any type of activatable implants (e.g. cardiac pacemakers, deep brain stimulators, spinal cord stimulators, cochlear implants, electronic infusion pumps, etc.)\n* Subjects with any type of metallic implants or foreign objects in torso region (e.g. cardiac stents, surgical clips, shrapnel fragments from war wounds, etc.)\n* metal works and machinists (who may have metallic fragments in or near the eyes)\n* severe auto accident victims\n* subjects with permanent tattoos that may contain metallic coloring\n* subjects with previous history of perforator flap surgery\n* subjects who cannot communicate with the researcher for any reason\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT03567018', 'briefTitle': 'Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Comprehensive Imaging of Perforator Vessels and Subcutaneous Vascular Network With No-Exogenous Contrast and Non-Ionizing-Radiation Magnetic Resonance Angiography', 'orgStudyIdInfo': {'id': 'RP0618/2012H0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteer population', 'description': 'We plan to enroll 25 healthy volunteers.', 'interventionNames': ['Device: MRI Scan']}, {'type': 'EXPERIMENTAL', 'label': 'Patient population', 'description': 'We plan to enroll 50 clinical patients who are receiving flap procedures at the Ohio State Medical Center.', 'interventionNames': ['Device: MRI Scan']}], 'interventions': [{'name': 'MRI Scan', 'type': 'DEVICE', 'description': 'Study participants will be scanned with a 3.0 Tesla Phillips Ingenia CX whole body clinical MRI system located at the Wright Center of Innovation at The Ohio State University Medical Center. Anatomical and angiographic MR images will be acquired for one of the most commonly used flap surgery donor perforators including but not limited to: the deep inferior epigastric perforators (DIEP); the superior gluteal arter perforators (SGAP); the inferior gluteal artery perforators (IGAP); the thoracodorsal artery perforators (TDAP); the anterolateral thigh perforators (ATL).', 'armGroupLabels': ['Healthy volunteer population', 'Patient population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Martha Morehouse Medical Plaza', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Michael V Knopp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wright Center of Innovation in Biomedical Imaging', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Michael V Knopp MD PhD', 'investigatorAffiliation': 'University of Cincinnati'}}}}