A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

Healthy Clinical Trial

Official title:

A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170531
• Other study ID #: 17-267
• Status: Completed
• Start date: May 23, 2017
• Est. completion date: April 26, 2021

Study information

• Verified date: May 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center