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

Metastatic Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05174026
• Other study ID #: 2017-0788
• Secondary ID: NCI-2019-0826120
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Malignant Neoplasm
• Metastatic Malignant Neoplasm in the Bone
• Neoplasms
• Neoplasms, Second Primary

Intervention

Other:
• Fludeoxyglucose F-18
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo 18F-FDG PET-MRI
• Positron Emission Tomography
Undergo 18F-FDG PET-MRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).		up to 6 months
Primary	Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.		up to 6 months

External Links

•   M D Anderson Cancer Center