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

M.D. Anderson Cancer Center10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Metastatic Malignant Neoplasm Metastatic Malignant Neoplasm in the Bone

Interventions

Fludeoxyglucose F-18OTHER

Given IV

Magnetic Resonance ImagingPROCEDURE

Undergo 18F-FDG PET-MRI

Positron Emission TomographyPROCEDURE

Undergo 18F-FDG PET-MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).

Time frame: up to 6 months

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

Time frame: up to 6 months

Data from ClinicalTrials.gov

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