A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan - Kettering Cancer Center

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom Designed Spine Coil

Diagnostic 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 coil

Diagnostic 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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: May 31, 2017
Registry last updated: May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed