18F-FDG PET-MRI for Planning and Follow-Up of Patients With Spine Tumors Treated With Spine Stereotactic Radiosurgery
NCT ID: NCT05174026
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2018-11-30
2024-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Fludeoxyglucose F-18
Given IV
Magnetic Resonance Imaging
Undergo 18F-FDG PET-MRI
Positron Emission Tomography
Undergo 18F-FDG PET-MRI
Interventions
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Fludeoxyglucose F-18
Given IV
Magnetic Resonance Imaging
Undergo 18F-FDG PET-MRI
Positron Emission Tomography
Undergo 18F-FDG PET-MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Behrang Amini
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2019-08261
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0788
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0788
Identifier Type: -
Identifier Source: org_study_id
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