18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery

Not Applicable

Completed

• Conditions: Metastatic Malignant Neoplasm; Metastatic Malignant Neoplasm in the Bone

• Registration Number: NCT05174026
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This trial studies how well 18F-FDG PET-MRI works for treatment planning in patients with spine tumors. Diagnostic procedures, such as 18F-FDG PET-MRI may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI) in spine stereotactic radiosurgery (SSRS) treatment planning compared to advanced MRI (aMRI) and conventional MRI (cMRI).

II. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients treated with SSRS.

SECONDARY OBJECTIVES:

I. Analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive PET/MRI features at baseline.

II. Analysis of the subset of patients who suffer complications of SSRS (e.g., vertebral compression fracture) to determine potential predictive imaging features.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute, and then undergo PET-MRI over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.

Study Timeline

• Study Start: 2018-11-30
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-30
• Status Verified: 2024-06
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Consent to imaging study
• Presence of at least 1 lumbar vertebral body bone metastasis > 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. Metastasis may be determined by pathology, or imaging appearance.
• Eligibility to receive SSRS (determined by treating radiation oncologists)
• Plan for single-fraction SSRS
• Standard-of-care spine MRI within 8 weeks of radiation therapy
• Ability to understand and willingness to sign a written informed consent document
• Non-English speaking participants will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking participants.

Exclusion Criteria

• Absolute or relative contra-indication to MRI, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan
• Prior directed radiation to the involved segment
• Contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy)
• Individuals younger than 18 years
• Hardware at the treatment level or hardware affecting visualization of the involved level on MRI
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).	up to 6 months
Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.	up to 6 months

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States