FDG PET-MRI for the Diagnosis of Spinal Cord Lesions

Spinal Cord Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219969
• Other study ID #: 2018-0144
• Secondary ID: NCI-2019-0822420
• Status: Completed
• Phase: N/A
• Start date: September 21, 2018
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 7, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Neoplasm
• Spinal Cord Neoplasms

Intervention

Drug:
• Fludeoxyglucose F-18
Given IV

Device:
• Magnetic Resonance Imaging
Undergo PET-MRI

Procedure:
• Positron Emission Tomography
Undergo PET-MRI

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard uptake value (SUV) max	Identifying the specific malignancy	Up to 8 hours
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center