Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04537403
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2020-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET Detection of CCR2 in Human Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of 64CU-ECL1i , imaging characteristics', 'timeFrame': '1 or 2 days', 'description': 'Injecting normal volunteers and patients who have blocked arteries with a single bolus injection. The dose of the injection is 8-10, and the above drug is measured in millicuries, which is a unit of radioactivity.\n\nthe dose of millicuries will be 8-10 millicures'}], 'secondaryOutcomes': [{'measure': 'PET/MR camera, imaging performance', 'timeFrame': '1-2 days', 'description': 'Utilizing the PET/MR camera using audiography, which can show the presence and size of the blockage'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carotid Atherosclerosis']}, 'descriptionModule': {'briefSummary': ': Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis', 'detailedDescription': 'Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis \\>70% and scheduled to undergo surgery. Advanced peripheral artery disease.\n\n\\-\n\nExclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male \\>2 drinks per day, and female \\> 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04537403', 'briefTitle': 'PET Detection of CCR2 in Human Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'PET Detection of CCR2 in Human Atherosclerosis', 'orgStudyIdInfo': {'id': '201911199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aim 1A', 'description': 'Normal volunteers and patients with Carotid and Femoral Atherosclerosis who will be having surgery', 'interventionNames': ['Drug: Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)']}, {'type': 'EXPERIMENTAL', 'label': 'Aim 1B', 'description': 'Patients with Carotid and Femoral Atherosclerosis who will be managed medically and not having surgery', 'interventionNames': ['Drug: Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)']}], 'interventions': [{'name': 'Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)', 'type': 'DRUG', 'description': 'Patients in Group 1, normal volunteers and patients with carotid and femoral artery disease who will be having surgery, will have a 1 day imaging session lasting approximately 60 minutes with an injection of 64CU-DOTA-ECL1i to visualize the carotid and femoral arteries. Patients with carotid and femoral artery disease will have their plaque specimens collected for further sutdy', 'armGroupLabels': ['Aim 1A']}, {'name': 'Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)', 'type': 'DRUG', 'description': 'Patients in Group 2, who are patients with carotid and femoral artery disease who will not be having surgery will have two imaging sessions 7-14 days apart', 'armGroupLabels': ['Aim 1B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Mohrman', 'role': 'CONTACT'}], 'facility': 'Washington University CCIR', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Kitty Harrison, BSN, RN', 'role': 'CONTACT', 'email': 'harrisonk@mir.wustl.edu', 'phone': '314-747-0183'}, {'name': 'Robert Gropler, M.D.', 'role': 'CONTACT', 'email': 'groplerr@mir.wustl.edu', 'phone': '314-747-0183'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}