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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05155423
• Collaborator: Elekta Limited (Industry)
• Enrollment: 47
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Metastases	Other: mask for immobilization; Other: Elekta BodyFix

Detailed Description

1. Objectives

2. 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).

3. 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.

4. Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (>3 consecutive vertebral body levels)

5. Optimize the workflow of using MRI simulation in treatment planning and dose delivery.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy
• Actual Study Start Date: Apr 21, 2018
• Anticipated Primary Completion Date: Apr 21, 2022
• Anticipated Study Completion Date: Apr 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
group 1 patient using mask for immobilization	Other: mask for immobilization; mask for immobilization
group 2 patients using Elekta BodyFix	Other: Elekta BodyFix; Elekta BodyFix

Outcome Measures

Primary Outcome Measures

1. Performing MRI scans in the treatment position for accurate treatment planning. [through study completion, an average of 1 year]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Elekta Limited

Investigators

• Principal Investigator: Amol Ghia, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05155423
• Other Study ID Numbers: PA18-0190
• First Posted: Dec 13, 2021
• Last Update Posted: Feb 21, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Feb 21, 2022