Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT03215550
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017585', 'term': 'Ultrasonography, Doppler, Transcranial'}], 'ancestors': [{'id': 'D004453', 'term': 'Echoencephalography'}, {'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'At the time of carotid endarterectomy, which is an established surgical intervention aimed at reducing the future risk of stroke in symptomatic patients, tissue will be collected, and lesion integrity and geometry will be preserved as much as possible. Specimens will be photographed in detail to permit subsequent assessment by independent and blinded reviewers. The excised tissue will be aligned and labelled to permit orientation in the carotid artery axis before undertaking 7.4 T magnetic resonance spectroscopy. Subsequently, carotid plaque will be snap frozen in liquid nitrogen. Cellular content, macrophage infiltration, apoptosis, and calcification-associated molecules within the plaques will be assessed by RNA analysis, immunohistochemistry and immunofluorescence using a variety of validated markers.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-07-10', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-fluoride uptake in the culprit plaque in carotid, aortic and intra-cranial vessels.', 'timeFrame': '2 weeks', 'description': '18F-fluoride uptake will be measured by the mean and max Standardised Uptake Values (SUV) derived from the culprit atherosclerotic plaques.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atherosclerosis, imaging'], 'conditions': ['Stroke', 'Carotid Stenosis']}, 'referencesModule': {'references': [{'pmid': '35670715', 'type': 'DERIVED', 'citation': 'Kaczynski J, Sellers S, Seidman MA, Syed M, Dennis M, Mcnaught G, Jansen M, Semple SI, Alcaide-Corral C, Tavares AAS, MacGillivray T, Debono S, Forsythe R, Tambyraja A, Slomka PJ, Leipsic J, Dweck MR, Whiteley W, Wardlaw J, van Beek EJR, Newby DE, Williams MC. 18F-NaF PET/MRI for Detection of Carotid Atheroma in Acute Neurovascular Syndrome. Radiology. 2022 Oct;305(1):137-148. doi: 10.1148/radiol.212283. Epub 2022 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.', 'detailedDescription': 'The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with evidence of an acute stroke, transient ischaemic attack or amaurosis fugax will be recruited as early as possible, but within 14 days of symptom onset. All patients will undergo careful clinical evaluation including carotid Doppler ultrasound assessment and magnetic resonance imaging of the brain. This cohort will be identified at the point they are referred to a vascular surgeon at Edinburgh Royal Infirmary.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients with carotid artery stenosis (\\>50% for men and \\>70% for women, by NASCET criteria) above 40 years of age.\n\nExclusion Criteria:\n\n* Patients with new stroke and a modified Rankin score \\>3\n* Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of \\<30 ml/min/1.73 m2\n* Atrial fibrillation\n* Pregnant women\n* Prior ipsilateral carotid intervention\n* Prior neck radiotherapy\n* Inability to tolerate the supine position\n* Participation in the study would result in delay to surgery\n* Psychiatric illness/social situations that would limit compliance with study requirements\n* History of allergic reaction attributed to 18F-fluoride\n* History of allergic reaction to gadolinium contrast media\n* Metal implants and devices including pacemakers and defibrillators'}, 'identificationModule': {'nctId': 'NCT03215550', 'briefTitle': 'PET-MRI Imaging in Patients With Symptomatic Carotid Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Hybrid 18F-fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Symptomatic Carotid Artery Stenosis', 'orgStudyIdInfo': {'id': 'AC17046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid Endarterectomy', 'description': 'Patients who are scheduled to undergo carotid endarterectomy for symptomatic carotid artery stenosis (≥50% by NASCET criteria for men, ≥70% for women) who are above 40 years of age.', 'interventionNames': ['Procedure: CEA', 'Radiation: 18F PET-MRI', 'Diagnostic Test: Transcranial Doppler']}], 'interventions': [{'name': 'CEA', 'type': 'PROCEDURE', 'description': 'Carotid Endarterectomy', 'armGroupLabels': ['Carotid Endarterectomy']}, {'name': '18F PET-MRI', 'type': 'RADIATION', 'description': '18F-fluoride Hybrid PET-MRI', 'armGroupLabels': ['Carotid Endarterectomy']}, {'name': 'Transcranial Doppler', 'type': 'DIAGNOSTIC_TEST', 'description': 'Microembolic Signals detection', 'armGroupLabels': ['Carotid Endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Centre for Cardiovascular Science', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}