Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine

January 22, 2024 updated by: Memorial Sloan Kettering Cancer Center

Assessment of a Custom-Built MRI Coil for Spine Radiotherapy Treatment Planning

Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants in this study will be identified by radiation oncologist study co-investigators who are involved in establishing the use of MRI for radiotherapy purposes.

Description

Inclusion Criteria:

  • >/= 18 years of age at the time of treatment
  • Able to give informed consent
  • Consented for spine stereotactic radiation therapy

  • No contraindications for CT myelograms which include:

    • Allergy to CT contrast
    • Use of phenothiazines
    • Platelet count < 60,000 K/mcl
    • INR > 1.5
    • VEGF inhibitor use in the past 2 weeks prior to myelogram
    • NSAID use in the past 5 days prior to myelogram
    • Renal disease
    • Creatinine > 1.2 mg/dL

  • No contraindications for MRI scans which include:

    • Newly placed glucose monitors
    • Tattoos (Tattoos for radiation therapy are allowed)
    • Presence of a cardiac pacemaker
    • Presence of an implanted cardioverter defibrillator
    • Breast tissue expander
    • Aneurysm clip
    • Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
    • Severe claustrophobia or inability to lie flat for the duration of the study, etc.

Exclusion Criteria:

  • Presence of surgical spine hardware at the region of interest
  • Presence of cervical spine lesions
  • History of claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thoracic, lumbar and sacral spine lesions
Participants will have thoracic, lumbar and sacral spine lesions
Diagnostic test: MRI with custom MRI spine coil
Participants will undergo MRI with custom MRI spine coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure
Time Frame: 6 months
The calculated doses to the cauda equine and spinal cord will be compared and evaluated for significant difference based upon the imaging modality (MRI coil vs CT myelogram) used to define each structure, with all other target and avoidance volumes being equal in the same patient.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Yoshiya Yamada, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Estimated)

January 9, 2025

Study Completion (Estimated)

January 9, 2025

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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