A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy

NCT ID: NCT05155423

Last Updated: 2025-11-19

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

ACTIVE_NOT_RECRUITING

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-21

Study Completion Date

2026-05-24

Brief Summary

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To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery.

Detailed Description

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1\. Objectives

1. Assess the feasibility of performing MRI scans in the treatment position for accurate treatment planning and dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
2. Characterize the improved accuracy of image fusion between MRI and CT and its dosimetric impact when performing MRI scans in treatment position in spinal SBRT.
3. Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (\>3 consecutive vertebral body levels)
4. Optimize the workflow of using MRI simulation in treatment planning and dose delivery.

Conditions

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Spinal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

patient using mask for immobilization

mask for immobilization

Intervention Type OTHER

mask for immobilization

group 2

patients using Elekta BodyFix

Elekta BodyFix

Intervention Type OTHER

Elekta BodyFix

Interventions

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mask for immobilization

mask for immobilization

Intervention Type OTHER

Elekta BodyFix

Elekta BodyFix

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Greater than or equal to 18 years of age
2. Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
3. Signed informed consent
4. Willing to undergo 2 MRI simulations in one or multiple sessions, one with immobilization device, and the other without.

Exclusion Criteria

a. Patient with a relative or absolute contraindication to MRI (such as pacemaker, etc.) b. Patients with significant instrumentation or cement at the site of interest causing artifact c. Inability to tolerate with immobilization device for greater than 30 minutes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elekta Limited

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amol Ghia, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2021-11703

Identifier Type: OTHER

Identifier Source: secondary_id

PA18-0190

Identifier Type: -

Identifier Source: org_study_id

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