We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Elucid Bioimaging
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02143102
First Posted: May 20, 2014
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elucid Bioimaging Inc.
  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 ]
    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 ]
    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.

Enrollment: 128
Study Start Date: July 2014
Study Completion Date: June 30, 2017
Primary Completion Date: March 14, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143102


Locations
United States, Louisiana
West Jefferson Medical Center
Marrero, Louisiana, United States, 70072
LSU ILH
New Orleans, Louisiana, United States, 70112
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
First Submitted: May 15, 2014
First Posted: May 20, 2014
Last Update Posted: November 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
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