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A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03170531
Enrollment
8
Registered
2017-05-31
Start date
2017-05-23
Completion date
2021-04-26
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

MRI, MR imaging, 17-267

Brief 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.

Interventions

DIAGNOSTIC_TESTCustom Designed Spine Coil

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.

DIAGNOSTIC_TESTFDA approved spine coil

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy Volunteers age 18 or older

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Optimize performanceDay of interventionOptimize 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 imagingDay of interventionTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026