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NCT05155423 Clinical Trial

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

Spinal Metastases Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05155423
Other study ID # PA18-0190
Secondary ID NCI-2021-11703
Status Suspended
Phase
First received
Last updated
Start date April 21, 2018
Est. completion date May 24, 2024

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Suspended
Enrollment 21
Est. completion date May 24, 2024
Est. primary completion date May 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 3.1. 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. 5. Patients undergoing spinal SBRT 3.2. 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• mask for immobilization
mask for immobilization
• Elekta BodyFix
Elekta BodyFix

Locations
Country Name City State
United States MD Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center Elekta Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Performing MRI scans in the treatment position for accurate treatment planning. through study completion, an average of 1 year
Primary Performing MRI scans in the treatment position for dose delivery in spinal stereotactic body radiation therapy (spinal SBRT). through study completion, an average of 1 year
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