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

A Pilot Study on the Efficacy of Advanced 18F-FDG PET-MRI in Spine Stereotactic Radiosurgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05174026

Enrollment

Registered

2021-12-30

Start date

2018-11-30

Completion date

2024-06-20

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Bone

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.

Interventions

OTHERFludeoxyglucose F-18

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo 18F-FDG PET-MRI

PROCEDUREPositron Emission Tomography

Undergo 18F-FDG PET-MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026