NCT05174026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

5.6 years

First QC Date

September 10, 2021

Last Update Submit

June 24, 2024

Conditions

Metastatic Malignant NeoplasmMetastatic Malignant Neoplasm in the Bone

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Diagnostic (18F-FDG PET-MRI)

EXPERIMENTAL

Patients receive fludeoxyglucose F-18 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.

Other: Fludeoxyglucose F-18Procedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Fludeoxyglucose F-18OTHER

Given IV

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Diagnostic (18F-FDG PET-MRI)
Magnetic Resonance ImagingPROCEDURE

Undergo 18F-FDG PET-MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (18F-FDG PET-MRI)
Positron Emission TomographyPROCEDURE

Undergo 18F-FDG PET-MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (18F-FDG PET-MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Behrang Amini

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

December 30, 2021

Study Start

November 30, 2018

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

US(1)