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Non-invasive Computer-Aided Phenotyping of Vasculopathy (Q-CAMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Elucid Bioimaging Inc.
Sponsor:
Information provided by (Responsible Party):
Elucid Bioimaging Inc.
ClinicalTrials.gov Identifier:
NCT02143102
First received: May 15, 2014
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.

Condition
Carotid Atherosclerosis
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy

Resource links provided by NLM:


Further study details as provided by Elucid Bioimaging Inc.:

Primary Outcome Measures:
  • Bias, precision, and reproducibility of plaque as assessed by MRI and/or CT analyzed by vascuCAP™ relative to histopathology as ground truth. [ Time Frame: Assessed on tissue samples collected within 30 days of MRI ] [ Designated as safety issue: No ]
    We use MRI and/or CT analyzed by vascuCAP™ to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAPTM measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling.


Secondary Outcome Measures:
  • Accuracy of plaque type characterization by MRI and/or CT analyzed by vascuCAP™ as compared to histopathology as ground truth [ Time Frame: Assessed on tissue samples collected within 30 days of MRI ] [ Designated as safety issue: No ]
    Classify the target lesion according to whether the analytes suggest it is not a plaque, or if it is, which of the 8 AHA types best fits the analyte profile. for each of the AHA types according to histopathology, we will report the frequency with which vascuCAPTM's classification agrees with histopathology.


Biospecimen Retention:   Samples Without DNA
After endarterectomy during surgery, the excised plaque specimens will be sent to the hospital's pathology lab to be analyzed.

Estimated Enrollment: 150
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Training set
Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.
Testing set
Data from subjects in the testing set will be used to assess the study endpoints.

Detailed Description:
The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. Study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAP™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:

  • Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study
  • Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study
Criteria

Inclusion Criteria:

Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:

  • Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study
  • Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study

Exclusion Criteria:

  • Subjects with claustrophobia or inability to tolerate prior MRI studies.
  • Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be attached) including: Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
  • Subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material.
  • Female subjects. A urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. Pregnant or nursing females will be excluded from the study.
  • Subjects who cannot adhere to the experimental protocol.
  • Subjects allergic to contrast material.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02143102

Contacts
Contact: Malachi Sheahan, M.D. (504) 412-1960 MSHEAH@LSUHSC.EDU

Locations
United States, Louisiana
West Jefferson Medical Center Recruiting
Marrero, Louisiana, United States, 70072
Principal Investigator: Robert Batson, M.D.         
LSU ILH Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Malachi Sheahan, M.D.         
Sponsors and Collaborators
Elucid Bioimaging Inc.
Investigators
Study Director: Andrew J. Buckler, M.S. Elucid Biomaging Inc.
  More Information

Responsible Party: Elucid Bioimaging Inc.
ClinicalTrials.gov Identifier: NCT02143102     History of Changes
Other Study ID Numbers: 305 
Study First Received: May 15, 2014
Last Updated: June 16, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Atherosclerosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2016