FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Not Applicable

Completed

• Conditions: Spinal Cord Neoplasm
• Interventions: Drug: Fludeoxyglucose F-18; Device: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

• Registration Number: NCT04219969
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-21
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Status Verified: 2024-05
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-FDG PET-MRI)	Fludeoxyglucose F-18	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.
Diagnostic (18F-FDG PET-MRI)	Magnetic Resonance Imaging	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.
Diagnostic (18F-FDG PET-MRI)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
Lesion to background (L/B) ratio	Up to 8 hours	L is the lesion metric (mean, max, etc.) and B is the corresponding background metric. These values will be plotted versus time and the delayed time point corresponding to the highest value for each metric recorded. Differences in L/B ratio will be tested via paired t-test.
Standard uptake value (SUV) max	Up to 8 hours	Identifying the specific malignancy
Optimal imaging time point	Up to 8 hours	Defined as the time point by which there is the largest average SUVmax L/B ratio and significantly different from baseline at the 0.025 significance level.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States