A Study Comparing Either Cervical Spine, Head, Temporal Bone or Vasculature Treated with Metallic Implants Imaged with CT or MRI or Cerebral Angiogram to a MRI Zero Echo Time (ZTE) MRI Sequence
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-009230
Sponsor Protocol Number: 17-009230
About this study
The purpose of this study is to demonstrate the use of 3D ZTE imaging of the cervical spine to assess osseous neural foraminal stenosis and directly compare it to CT. Other objectives will include evaluation of ossification of the posterior longitudinal ligament, ossification of disc herniations, and comparison of ZTE derived imaging of pedicle morphology to the current reformats provided by CT. The ability to image metallic hardware with ZTE will also be assessed, if present; 56 participants. Other cohorts being added is for those who are returning for aneursym ablation follow-up with medically indicated head MRI (adding reserach ZTE sequence) and a head angiogram 100 participants; ZTE MRI of C-Spine with or without head MRI for those having migraine assessment, 30 participants; ZTE MRI Head of temporal bone for pre or post cochlear assessment, 30 participants; ZTE MRI of Venous Stenting comparison to angiogram, 30 participants. Total 246 participants.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient’s scheduled to have a MRI and a CT of the cervical spine within six months of each other in the Neuroradiology practice as medically indicated; or using outside CT exam if on EHR and within six months of MRI. Adding research ZTE sequence to MRI scan.
- Patient's scheduled to have MRI and conventional angiogram post aneursym ablation as medically indicated, adding reserach ZTE sequence to MRI scan.
- Patients scheduled to have MRI of head for temporal bone assessment pre or post cochlear implant.
- Patients scheduled for MRI of C-Spine with or without Head for assessment of migraine trigger.
- Patients scheduled for MRI of Venous Stenting assessment.
- Exclusion Criteria:
- Any patient with metal hardware present in their cervical spine that interferes with greater than two vertebrae, pacermaker or other device implanted. Those with aneursym clips, coils, stents may be enrolled if item is MRI conditional safe for scanning.
- Those who have devices not compatible or safe for MRI of 7 Tesla strength.
- Patient will be exclude if they cervical spinal surgery between exams.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aiming Lu, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available