Aortic Aneurysm, Abdominal Clinical Trial
Official title:
Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
NCT number | NCT02995642 |
Other study ID # | 26885 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | December 2020 |
Verified date | May 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke and abdominal aortic aneurysms (AAAs) are common and highly lethal vascular diseases. Angiogenesis and infiltration of inflammatory cells such as macrophages may cause stroke and AAAs. The purpose of this study is to test PET/CT and PET/MRI imaging to specifically detect those diseases using a new developed agent (18F-FPPRGD2) that can target angiogenesis and macrophages.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Greater than 18 year-old at the time of radiotracer administration - Provides written informed consent - Patients diagnosed with either carotid artery stenosis or abdominal aortic aneurysms (AAAs) as identified in Vascular Surgery, in whom a surgical procedure is scheduled - Able to remain still for duration of an imaging procedure (about one hour). Exclusion Criteria: - Less than 18 year-old at the time of radiotracer administration - Unable to provide written informed consent - Pregnant women - Prior carotid or abdominal surgery - History of radiation therapy to the neck and abdomen - MRI contraindications (including ferromagnetic objects or devices). |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Kitagawa T, Kosuge H, Chang E, James ML, Yamamoto T, Shen B, Chin FT, Gambhir SS, Dalman RL, McConnell MV. Integrin-targeted molecular imaging of experimental abdominal aortic aneurysms by (18)F-labeled Arg-Gly-Asp positron-emission tomography. Circ Cardiovasc Imaging. 2013 Nov;6(6):950-6. doi: 10.1161/CIRCIMAGING.113.000234. Epub 2013 Aug 30. — View Citation
Mittra ES, Goris ML, Iagaru AH, Kardan A, Burton L, Berganos R, Chang E, Liu S, Shen B, Chin FT, Chen X, Gambhir SS. Pilot pharmacokinetic and dosimetric studies of (18)F-FPPRGD2: a PET radiopharmaceutical agent for imaging a(v)ß(3) integrin levels. Radiology. 2011 Jul;260(1):182-91. doi: 10.1148/radiol.11101139. Epub 2011 Apr 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUVmax of 18F-FPPRGD2 uptake by lesions (carotid atherosclerotic plaque or AAA). | The arterial standardized uptake value (SUV) for carotid plaque or AAA will be calculated as the mean pixel activity within the region of interest (ROI).
By averaging the SUV values for each artery slice, we will derived a mean SUV value for the entire artery (arterial SUV). This will be corrected for blood activity by division by the average blood SUV estimated from either the inferior vena cava or jugular vein to produce a blood-corrected artery SUV, known as the arterial tissue-to-background ratio (TBR). |
Up to 60 minutes post-injection (at time of scan) | |
Primary | Percent agreement of 18F-FPPRGD2 PET with pathology | After the planned surgical procedure, the accuracy of 18F-FPPRGD2 PET as percent agreement with pathology (including angiogenesis and inflammation assessment) will be calculated. | Up to 60 minutes post-injection (at time of scan) |
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