FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

NCT ID: NCT04219969

Last Updated: 2024-05-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-21

Study Completion Date

2024-05-07

Brief Summary

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To compare the results and understand the possible benefits from FDG-PET/MRI during different scanning time points after FDG, a type of contrast drug, is given.

Detailed Description

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Primary Objectives:

--To identify the optimal imaging time point using F18-FDG positron emission tomography (PET) that gives the best lesion conspicuity as defined by the best lesion to background (L/B) ratio when evaluating spinal cord lesions of unknown etiology.

Exploratory Objectives:

* To identify malignancy specific factors in F18-FDG metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), metabolic tumor volume (MTV) and L/B ratio.
* To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values and mean diffusivity measures.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minutes and then undergo PET-magnetic resonance imaging (MRI) over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.

Conditions

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Spinal Cord Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (18F-FDG PET-MRI)

Patients receive fludeoxyglucose F-18 IV over 1 minutes and then undergo PET-MRI over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.

Group Type EXPERIMENTAL

Fludeoxyglucose F-18

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type DEVICE

Undergo PET-MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET-MRI

Interventions

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Fludeoxyglucose F-18

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo PET-MRI

Intervention Type DEVICE

Positron Emission Tomography

Undergo PET-MRI

Intervention Type PROCEDURE

Other Intervention Names

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18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI nuclear magnetic resonance imaging Medical Imaging, Positron Emission Tomography PET PET scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Patients with untreated intramedullary cord lesion(s)
* Ability to undergo FDG PET MR examination

Exclusion Criteria

* No prior surgery or biopsy of the spinal cord
* No metal implanted in area of interest
* Spine radiation therapy
* Known allergy to FDG or gadolinium based contrast agents
* Blood glucose (\> 200 mg/dl)
* Pregnant women are excluded
* Children of less than 18 years of age
* Need for conscious sedation or anesthesia in order to tolerate study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria K Gule-Monroe

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2019-08224

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0144

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0144

Identifier Type: -

Identifier Source: org_study_id

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