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

NCT ID: NCT04227717

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2025-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Cancer Spine Cancer Thoracic Diseases Spine Disease Thoracic Neoplasms Spine Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Thoracic, lumbar and sacral spine lesions

Participants will have thoracic, lumbar and sacral spine lesions

Group Type EXPERIMENTAL

MRI with custom MRI spine coil

Intervention Type DIAGNOSTIC_TEST

Participants will undergo MRI with custom MRI spine coil

Interventions

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MRI with custom MRI spine coil

Participants will undergo MRI with custom MRI spine coil

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoshiya Yamada, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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19-476

Identifier Type: -

Identifier Source: org_study_id

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