NCT04227717

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

5.5 years

First QC Date

January 10, 2020

Last Update Submit

July 16, 2025

Conditions

Thoracic CancerSpine CancerThoracic DiseasesSpine DiseaseThoracic NeoplasmsSpine Metastases

Keywords

Thoracic lesionsLumbar lesionsSacral spine lesionsMRI Coilspine radiotherapyMemorial Sloan Kettering Cancer Center19-476

Outcome Measures

Primary Outcomes (1)

  • Difference of calculated doses to the cauda equine and spinal cord based upon MRI coil vs CT myelogram used to define each structure

    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

Study Arms (1)

Thoracic, lumbar and sacral spine lesions

EXPERIMENTAL

Participants will have thoracic, lumbar and sacral spine lesions

Diagnostic Test: MRI with custom MRI spine coil

Interventions

MRI with custom MRI spine coilDIAGNOSTIC_TEST

Participants will undergo MRI with custom MRI spine coil

Thoracic, lumbar and sacral spine lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>/= 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)
  • +6 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord NeoplasmsThoracic DiseasesSpinal DiseasesThoracic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesRespiratory Tract DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Yoshiya Yamada, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

January 9, 2020

Primary Completion

July 14, 2025

Study Completion

July 14, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)