A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

Completed

• Conditions: Healthy
• Interventions: Diagnostic Test: Custom Designed Spine Coil; Diagnostic Test: FDA approved spine coil

• Registration Number: NCT03170531
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-23
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Healthy Volunteers age 18 or older

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Custom MR spine coil	FDA approved spine coil	-
Custom MR spine coil	Custom Designed Spine Coil	-

Primary Outcome Measures

Name	Time	Method
Optimize performance	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	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.

Trial Locations

Locations (1)

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States