- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174026
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Behrang Amini
- Phone Number: 713-792-5181
- Email: bamini@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Given IV
Other Names:
Undergo 18F-FDG PET-MRI
Other Names:
Undergo 18F-FDG PET-MRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the therapeutic efficacy of fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)-magnetic resonance imaging (MRI).
Time Frame: up to 6 months
|
up to 6 months
|
Determine the diagnostic accuracy of 18F-FDG PET-MRI in follow-up of patients.
Time Frame: up to 6 months
|
up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Behrang Amini, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0788 (Other Identifier: M D Anderson Cancer Center)
- NCI-2019-08261 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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