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

NCT05155423 | Active Not Recruiting

• 2 other identifiers: PA18-0190NCI-2021-11703
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Metastases

Outcome Measures

Primary Outcomes (2)

• Performing MRI scans in the treatment position for accurate treatment planning.

  through study completion, an average of 1 year

• 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

Study Arms (2)

group 1

patient using mask for immobilization

Other: mask for immobilization

group 2

patients using Elekta BodyFix

Other: Elekta BodyFix

Interventions

mask for immobilization OTHER

mask for immobilization

group 1

Elekta BodyFix OTHER

Elekta BodyFix

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MDACC Cancer Participants

You may qualify if:

• Greater than or equal to 18 years of age
• 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
• Signed informed consent
• Willing to undergo 2 MRI simulations in one or multiple sessions, one with immobilization device, and the other without.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Elekta Limited: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Masks; Immobilization

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Investigative Techniques

Study Officials

• Amol Ghia, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: April 21, 2018
• Primary Completion (Estimated): May 24, 2026
• Study Completion (Estimated): May 24, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)