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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Custom Designed Spine Coil; Diagnostic test: FDA approved spine coil

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan - Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Custom MR spine coil

Diagnostic test: Custom 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 test: FDA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day of intervention

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: MRI; MR imaging; 17-267
• Other Study ID Numbers: 17-267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No