18F-FDG PET-MRI for Planning and Follow-Up of Patients Wi... | NCT05174026

ID	Type	Description	Link
NCI-2019-08261	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2017-0788	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Jun 20, 2024Actual

Completion Date

Jun 20, 2024Actual

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Dec 13, 2021

First Posted Date

Dec 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2024

Last Update Posted Date

Jun 25, 2024Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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-18 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fludeoxyglucose F-18	Other	Given IV	Diagnostic (18F-FDG PET-MRI)	18FDG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019788	Fluorodeoxyglucose F18
D009682	Magnetic Resonance Spectroscopy

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques