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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05174026
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
1
Arm
49
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fludeoxyglucose F-18
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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).

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

SECONDARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study on the Efficacy of Advanced 18F-FDG PET-MRI in Spine Stereotactic Radiosurgery
Actual Study Start Date :
Nov 30, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (18F-FDG PET-MRI)

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-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • Fludeoxyglucose (18F)
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

    • Procedure: Magnetic Resonance Imaging
    Undergo 18F-FDG PET-MRI
    Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

    • Procedure: Positron Emission Tomography
    Undergo 18F-FDG PET-MRI
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI). [up to 6 months]

    2. Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients. [up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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)

    • Hardware at the treatment level or hardware affecting visualization of the involved level on MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Behrang Amini, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05174026
    Other Study ID Numbers:
    • 2017-0788
    • NCI-2019-08261
    • 2017-0788
    First Posted:
    Dec 30, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Neoplasms, Second Primary
    Deoxyglucose
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Aug 12, 2022