FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Neoplasm
• Intervention / Treatment: Drug: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography; Device: Magnetic Resonance Imaging

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria K. Gule-Monroe; Phone Number: 281-546-7750; Email: mgule@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Fludeoxyglucose F-18; Given IV; Other Names: 18FDG; FDG; fludeoxyglucose F 18; Fludeoxyglucose (18F); Fludeoxyglucose F18; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Fluorodeoxyglucose F18; Procedure: Positron Emission Tomography; Undergo PET-MRI; Other Names: Medical Imaging, Positron Emission Tomography; PET; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PET scan; Device: Magnetic Resonance Imaging; Undergo PET-MRI; Other Names: MRI; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI Scan; NMR Imaging; NMRI; nuclear magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard uptake value (SUV) max	Identifying the specific malignancy	Up to 8 hours
Lesion to background (L/B) ratio	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.	Up to 8 hours
Optimal imaging time point	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.	Up to 8 hours

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Maria K Gule-Monroe, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 4, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Cord Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Radiopharmaceuticals; Fluorodeoxyglucose F18; Deoxyglucose
• Other Study ID Numbers: 2018-0144 (Other Identifier: M D Anderson Cancer Center); NCI-2019-08224 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No