Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-20 @ 3:23 PM
Study NCT ID:
NCT03647566
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2018-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D000094667', 'term': 'Penetrating Atherosclerotic Ulcer'}], 'ancestors': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Aortic tissue specimens obtained from individuals undergoing open surgical repair will be studied histologically, using autoradiography and micro-PET/CT'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue', 'timeFrame': '12 to 36 months', 'description': 'Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained from participants undergoing open surgical repair.'}], 'primaryOutcomes': [{'measure': 'Aortic diameter', 'timeFrame': '12 months', 'description': 'Maximum cross-sectional aortic diameter'}], 'secondaryOutcomes': [{'measure': '18F Sodium Fluoride uptake in the aorta', 'timeFrame': '12 months', 'description': '18F Sodium Fluoride binding in the aorta will be measured from PET/CT scans performed at recruitment and at 12 months follow-up. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.'}, {'measure': 'Hospital admissions', 'timeFrame': '24 months', 'description': 'The requirement for hospital admission'}, {'measure': 'Surgical Intervention', 'timeFrame': '24 months', 'description': 'Requirement for surgical intervention during follow-up period'}, {'measure': 'Change in renal function', 'timeFrame': '24 months', 'description': 'Creatinine change during the follow-up period'}, {'measure': 'Short Form-12 (SF12) questionnaire score', 'timeFrame': '24 months', 'description': 'The SF12 is a validated, self reported quality of life assessment questionnaire. It consists of 12 questions that measure functional and mental well-being. Scores range from 12 to 47.'}, {'measure': 'Disease related survival', 'timeFrame': '24 months', 'description': 'Disease related survival'}, {'measure': 'All-cause mortality', 'timeFrame': '24 months', 'description': 'All-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sodium fluoride', 'positron emission tomography', 'computed tomography', 'acute aortic syndrome', 'aortic dissection', 'intramural haematoma', 'penetrating aortic ulcer'], 'conditions': ['Acute Aortic Syndrome', 'Aortic Dissection', 'Penetrating Aortic Ulcer', 'Intramural Hematoma']}, 'referencesModule': {'references': [{'pmid': '35798405', 'type': 'DERIVED', 'citation': 'Syed MBJ, Fletcher AJ, Debono S, Forsythe RO, Williams MC, Dweck MR, Shah ASV, Macaskill MG, Tavares A, Denvir MA, Lim K, Wallace WA, Kaczynski J, Clark T, Sellers SL, Masson N, Falah O, Chalmers RTA, Tambyraja AL, van Beek EJR, Newby DE. 18F-Sodium Fluoride Positron Emission Tomography and Computed Tomography in Acute Aortic Syndrome. JACC Cardiovasc Imaging. 2022 Jul;15(7):1291-1304. doi: 10.1016/j.jcmg.2022.01.003. Epub 2022 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.', 'detailedDescription': 'Acute Aortic Syndrome encompasses multiple aortopathies, including aortic dissection, intramural haematoma and penetrating aortic ulcers. Acute aortic syndrome has a three year mortality approaching 25%. To date, other than the initial aortic diameter, there are no accurate methods of establishing the risk of disease progression in patients with acute aortic syndrome.\n\nIn vascular disease, microcalcification occurs in response to necrotic inflammation. Using computed tomography and positron emission tomography (PET-CT), early microcalcification can be identified using uptake of the radiotracer 18F-sodium fluoride. This can identify high risk-lesions in the aorta, coronary and carotid arteries, and appears to be indicative of necrotic and heavily inflamed tissue. In abdominal aortic aneurysms, 18F-sodium fluoride binding predicts aortic expansion and the risk of aneurysm rupture or requirement for surgical repair.\n\nThe study investigators, therefore, propose to evaluate the ability of 18F-sodium fluoride to identify regions of necrotic inflammation in acute aortic syndrome to predict aortic expansion and disease progression.\n\nControl patients with a normal calibre aorta will be recruited from the National Abdominal Aortic Aneurysm Screening Programme and Vascular Out-Patient Clinics. Patients with acute aortic syndrome and chronic aortic disease will undergo clinical assessments and 18F Sodium Fluoride PET/CT scans at baseline and 12-months. Clinical follow-up will continue for up to 3 years from recruitment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with acute aortic syndrome will be recruited from emergency hospital admissions. Participants with chronic aortic disease will be recruited from out-patient clinics and thoracic aortic surveillance programmes. Healthy volunteers will be recruited from the national abdominal aortic aneurysm screening service and vascular out-patient department clinics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nPatients with Acute Aortic Syndrome or Chronic Aortic Disease:\n\n* A diagnosis of acute aortic syndrome as defined as per the European Society of Cardiology guidelines on the management of aortic disease a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.\n* Adults over the age of 25 years\n* Participants who have had previous open or thoracic endovascular aortic repair (TEVAR) are eligible to participate in the study.\n\nHealthy Controls:\n\n* No previous diagnosis of aortic disease\n* Over the age of 55 years\n\nEXCLUSION CRITERIA:\n\n* The inability of patients to undergo PET/CT scanning\n* Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)\n* Major or untreated cancer\n* Pregnancy\n* Allergy or contra-indication to iodinated contrast\n* Inability or unwillingness to give informed consent'}, 'identificationModule': {'nctId': 'NCT03647566', 'acronym': 'FAASt', 'briefTitle': '18F Sodium Fluoride PET/CT in Acute Aortic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': '18F Sodium Fluoride PET/CT in Acute Aortic Syndrome', 'orgStudyIdInfo': {'id': 'AC18044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Aortic Disease', 'description': 'Participants with normal calibre aortae and no prior diagnosis of acute aortic syndrome', 'interventionNames': ['Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography', 'Diagnostic Test: Aortic MRI']}, {'label': 'Acute Aortic Syndrome', 'description': 'Participants presenting acutely with a diagnosis of acute aortic syndrome as defined in the European Society of Cardiology guidelines: a compatible clinical presentation with CT or magnetic resonance imaging confirming acute aortic syndrome.', 'interventionNames': ['Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography', 'Diagnostic Test: CT Aortic Angiogram']}, {'label': 'Chronic Aortic Disease', 'description': 'Participants with an established diagnosis of acute aortic syndrome.', 'interventionNames': ['Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography', 'Diagnostic Test: CT Aortic Angiogram']}], 'interventions': [{'name': '18F Sodium Fluoride Positron Emission Tomography / Computed Tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan', 'armGroupLabels': ['Acute Aortic Syndrome', 'Chronic Aortic Disease', 'No Aortic Disease']}, {'name': 'CT Aortic Angiogram', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT scan to assess aortic morphology and contextualise PET scan', 'armGroupLabels': ['Acute Aortic Syndrome', 'Chronic Aortic Disease']}, {'name': 'Aortic MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aortic MRI to assess aortic morphology and contextualise PET scan', 'armGroupLabels': ['No Aortic Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Maaz BJ Syed, MBChB MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared outside the current research group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'British Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}