Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:25 PM
Study NCT ID:
NCT07473102
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Imaging of MMP Activation in AAA: Clinical Component
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verification Cu-64RYM2-2 signal in AAA segments. This will be performed by measuring Standard Uptake Values obtained from analysis of the Cu-64RYM2 images, in AAA patients.', 'timeFrame': '2 years', 'description': 'Verification Cu-64RYM-2 signal is present in AAA segment of the abdominal aorta'}], 'secondaryOutcomes': [{'measure': 'Cu-64RYM-2 signal is higher', 'timeFrame': '2 years', 'description': 'MMP activity will be higher in AAA patients than in healthy volunteers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaging for Aneurysm Abdominal', 'Imaging for Abdominal Aneurysms'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '18936327', 'type': 'BACKGROUND', 'citation': 'Zhang J, Nie L, Razavian M, Ahmed M, Dobrucki LW, Asadi A, Edwards DS, Azure M, Sinusas AJ, Sadeghi MM. Molecular imaging of activated matrix metalloproteinases in vascular remodeling. Circulation. 2008 Nov 4;118(19):1953-60. doi: 10.1161/CIRCULATIONAHA.108.789743. Epub 2008 Oct 20.'}, {'pmid': '26352243', 'type': 'BACKGROUND', 'citation': 'Davis FM, Rateri DL, Daugherty A. Abdominal aortic aneurysm: novel mechanisms and therapies. Curr Opin Cardiol. 2015 Nov;30(6):566-73. doi: 10.1097/HCO.0000000000000216.'}, {'pmid': '27903546', 'type': 'BACKGROUND', 'citation': 'Curci JA, Beckman JA. Positron Emission Tomography Fluorine-18-Labeled 2-Deoxy-2-Fluoro-d-Glucose Tells a Complicated Story in the Aortic Aneurysm Wall. Circ Cardiovasc Imaging. 2016 Nov;9(11):e005689. doi: 10.1161/CIRCIMAGING.116.005689. No abstract available.'}, {'pmid': '24381115', 'type': 'BACKGROUND', 'citation': 'Golestani R, Sadeghi MM. Emergence of molecular imaging of aortic aneurysm: implications for risk stratification and management. J Nucl Cardiol. 2014 Apr;21(2):251-67; quiz 268-70. doi: 10.1007/s12350-013-9845-5. Epub 2014 Jan 1.'}, {'pmid': '25427112', 'type': 'BACKGROUND', 'citation': 'Kent KC. Clinical practice. Abdominal aortic aneurysms. N Engl J Med. 2014 Nov 27;371(22):2101-8. doi: 10.1056/NEJMcp1401430. No abstract available.'}, {'pmid': '25060754', 'type': 'BACKGROUND', 'citation': 'Davis FM, Rateri DL, Daugherty A. Mechanisms of aortic aneurysm formation: translating preclinical studies into clinical therapies. Heart. 2014 Oct;100(19):1498-505. doi: 10.1136/heartjnl-2014-305648. Epub 2014 Jul 24.'}, {'pmid': '26763279', 'type': 'BACKGROUND', 'citation': 'Toczek J, Meadows JL, Sadeghi MM. Novel Molecular Imaging Approaches to Abdominal Aortic Aneurysm Risk Stratification. Circ Cardiovasc Imaging. 2016 Jan;9(1):e003023. doi: 10.1161/CIRCIMAGING.115.003023.'}]}, 'descriptionModule': {'briefSummary': 'A first-in-human evaluation of \\[64Cu\\]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).', 'detailedDescription': 'A first-in-human evaluation of \\[64Cu\\]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Healthy Volunteers\n\n* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions.\n* Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.\n* Capable of lying still and supine within the PET/CT scanner for \\~1 hour and follow instructions for breathing protocol during the CT portion.\n* No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year.\n* No known history of cardiac, pulmonary, hepatic or renal disease or diabetes\n* BMI ≤ 40\n\nExclusion Criteria: Healthy Volunteers\n\n* Inability to receive and sign informed consent;\n* Pregnant (confirmed by urine pregnancy test) and/or breastfeeding\n* Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL/min/1.73 m2\n* Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.\n* Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).\n* Currently using recreational drugs.\n* Body weight of \\>300 lbs. (weight limit of the PET table).\n* Currently enrolled in another study using an investigational drug or underwent a study the last year involving investigational use of radiotracers or CT would confound results or with a radiation exposure when combined with this study would be deemed as excessive by the Sponsor-Investigator.\n\nInclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair\n\n* Men or women 40-80 years of age\n* Willing and able to provide informed consent\n* Medically managed hypertension and hyperlipidemia\n* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions\n* Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol\n* Patients with AAA indicated for surgical repair (5.0 \\[female\\] - 5.5cm \\[male\\]), incidentally identified large(r) AAAs (\\>5.5 or 6.0 cm), and rapidly expanding AAAs (\\> 0.5 cm in 6 months or \\> 1 cm in 12 months) per Guidelines of the Society for Vascular Surgery.\n\nExclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair\n\n* Inability to receive and sign informed consent.\n* Currently enrolled in another study using an investigational drug\n* Pregnant (confirmed by urine pregnancy test) and/or breastfeeding\n* Patient with chronic renal disease whose GFR is less than 30 mL/min/1.73 m2\n* Documented allergy to iodinated contrast and/or shellfish\n* Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.\n* Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET/CT.\n* Other conditions such as symptomatic/recently treated coronary disease, cancer requiring oncologic management, or autoimmune/inflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis).\n* Non-AAA volunteers may not carry a diagnosis of aortoiliac occlusive disease, as documented by their treating vascular surgeon, as significantly progressed atherosclerotic disease may demonstrate exaggerated, associated MMP activity.'}, 'identificationModule': {'nctId': 'NCT07473102', 'acronym': 'PET AAA', 'briefTitle': 'PET Imaging of MMP Activation in AAA: Clinical Component', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'PET Imaging of MMP Activation in AAA: Clinical Component', 'orgStudyIdInfo': {'id': '202505027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'dosimetry and AAA patients', 'description': 'Patients who have abdominal aortic aneurysm and healthy volunteers', 'interventionNames': ['Drug: Cu-64-RYM2', 'Drug: PET imaging using Cu-64']}], 'interventions': [{'name': 'Cu-64-RYM2', 'type': 'DRUG', 'description': 'PET/CT scan', 'armGroupLabels': ['dosimetry and AAA patients']}, {'name': 'PET imaging using Cu-64', 'type': 'DRUG', 'description': 'PET/CT at different timepoints', 'armGroupLabels': ['dosimetry and AAA patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kitty Harrison, RN, BSN', 'role': 'CONTACT', 'email': 'kittydharrison@wustl.edu', 'phone': '314-747-0183'}, {'name': 'Robert Gropler, MD', 'role': 'CONTACT', 'phone': '314-747-0183'}, {'name': 'Robert Gropler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Kitty Harrison, RN, BSN', 'role': 'CONTACT', 'email': 'kittydharrison@wustl.edu', 'phone': '314-747-0183'}, {'name': 'Robert Gropler, MD', 'role': 'CONTACT', 'email': 'rgropler@wustl.edu', 'phone': '314-747-0183'}], 'overallOfficials': [{'name': 'Robert Gropler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only de-identified images will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}