HealthyNCT03170531
A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning
An observational study of Healthy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Custom Designed Spine Coil and FDA approved spine coil
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 26 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enrollment in this study will be open to all MSKCC employees to act as healthy volunteers provided they meet the eligibility criteria for the protocol. Employees who provide consent willfully and voluntarily may participate as a healthy volunteer once. Employees who are under direct supervision of any investigators on the study will not be eligible to participate. An IRB approved flyer with pertinent contact information will be distributed throughout the institution to inform all MSKCC employees of the possibility of participating in this study. No preferences will be given by race or gender for the selection of participants.
Who may be able to join
- Healthy Volunteers age 18 or older
Who cannot join
- Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
- Volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- Female volunteers who are pregnant or nursing
- Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
- Volunteers who are under direct supervision of any investigators on the study will not be eligible to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
About this study
The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning.
- Conditions
- Healthy
- Being tested
- Custom Designed Spine Coil, FDA approved spine coil
- Keywords
- MRI, MR imaging, 17-267
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom Designed Spine CoilDiagnostic test
During the participant's MR scan, the custom spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging.
FDA approved spine coilDiagnostic test
During the participant's MR scan, the FDA spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging. Volunteers may receive up to 3 scans to allow for comparisons of changes to the calibration files as we continue to test the coil and improve its performance.
| Study group | Role | What they receive |
|---|---|---|
| Custom MR spine coil | Not described Receives: Diagnostic Test: Custom Designed Spine Coil; Diagnostic Test: FDA approved spine coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimize performance
Optimize performance of custom-designed spine coil in RT configuration on participants. This objective focuses on the technology of the custom designed spine coil and does not require any statistical analysis.
Measured: Day of intervention
Compare the signal-to-noise ratio of a custom spine coil with the existing FDA approved posterior coil array used for spine imaging
To quantify image quality obtained from the custom spine coil and the existing coil, SNR will be calculated (see Section 4.1 for details) for both coils. If, for a volunteer, the SNR from the custom coil is larger than 105% of that from the existing coil (we insist a 5% improvement margin due to anticipated uncertainty and variability), then we will classify this sample point as a "success". We will combine the 15 volunteers from the three cohorts (cervical-spine, thoracic-spine and lumbar-spine) and impose the following decision rule: If at least 12 out of the total 15 volunteers are success, then we declare the custom designed spine coil promising and worthy of further investigation.
Measured: Day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start23 May 2017
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170531
- Sponsor's protocol ID
- 17-267
- Status last verified
- May 2021
- First submitted
- 26 May 2017
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning
- ClinicalTrials.gov ID
- NCT03170531
- Acronym / sponsor ID
- 17-267
- Conditions
- Healthy
- Keywords
- MRI, MR imaging, 17-267
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Custom MR spine coil | – | Diagnostic Test: Custom Designed Spine Coil, Diagnostic Test: FDA approved spine coil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment in this study will be open to all MSKCC employees to act as healthy volunteers provided they meet the eligibility criteria for the protocol. Employees who provide consent willfully and voluntarily may participate as a healthy volunteer once. Employees who are under direct supervision of any investigators on the study will not be eligible to participate. An IRB approved flyer with pertinent contact information will be distributed throughout the institution to inform all MSKCC employees of the possibility of participating in this study. No preferences will be given by race or gender for the selection of participants.
Key inclusion criteria (1 listed)
- Healthy Volunteers age 18 or older
Key exclusion criteria (5 listed)
- Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
- Volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- Female volunteers who are pregnant or nursing
- Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
- Volunteers who are under direct supervision of any investigators on the study will not be eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom Designed Spine CoilDuring the participant's MR scan, the custom spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging. | Diagnostic test | Custom MR spine coil |
| FDA approved spine coilDuring the participant's MR scan, the FDA spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging. Volunteers may receive up to 3 scans to allow for comparisons of changes to the calibration files as we continue to test the coil and improve its performance. | Diagnostic test | Custom MR spine coil |
Primary outcome
Optimize performance
Time frame: Day of intervention
Optimize performance of custom-designed spine coil in RT configuration on participants. This objective focuses on the technology of the custom designed spine coil and does not require any statistical analysis.
Compare the signal-to-noise ratio of a custom spine coil with the existing FDA approved posterior coil array used for spine imaging
Time frame: Day of intervention
To quantify image quality obtained from the custom spine coil and the existing coil, SNR will be calculated (see Section 4.1 for details) for both coils. If, for a volunteer, the SNR from the custom coil is larger than 105% of that from the existing coil (we insist a 5% improvement margin due to anticipated uncertainty and variability), then we will classify this sample point as a "success". We will combine the 15 volunteers from the three cohorts (cervical-spine, thoracic-spine and lumbar-spine) and impose the following decision rule: If at least 12 out of the total 15 volunteers are success, then we declare the custom designed spine coil promising and worthy of further investigation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimize performance (time frame: Day of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.