FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Overview

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.

Full Title of Study: “Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2024

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.

Interventions

  • Drug: Fludeoxyglucose F-18
    • Given IV
  • Device: Magnetic Resonance Imaging
    • Undergo PET-MRI
  • Procedure: Positron Emission Tomography
    • Undergo PET-MRI

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maria K Gule-Monroe, Principal Investigator, M.D. Anderson Cancer Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.