Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine (NCT04227717) | Clinical Trial Compass
CompletedNot Applicable
Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine
United States9 participantsStarted 2020-01-09
Plain-language summary
Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>/= 18 years of age at the time of treatment
* Able to give informed consent
* Consented for spine stereotactic radiation therapy
* No contraindications for CT myelograms which include:
* Allergy to CT contrast
* Use of phenothiazines
* Platelet count \< 60,000 K/mcl
* INR \> 1.5
* VEGF inhibitor use in the past 2 weeks prior to myelogram
* NSAID use in the past 5 days prior to myelogram
* Renal disease
* Creatinine \> 1.2 mg/dL
* No contraindications for MRI scans which include:
* Newly placed glucose monitors
* Tattoos (Tattoos for radiation therapy are allowed)
* Presence of a cardiac pacemaker
* Presence of an implanted cardioverter defibrillator
* Breast tissue expander
* Aneurysm clip
* Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
* Severe claustrophobia or inability to lie flat for the duration of the study, etc.
Exclusion Criteria:
* Presence of surgical spine hardware at the region of interest
* Presence of cervical spine lesions
* History of claustrophobia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure