NCT04219969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5.6 years

First QC Date

December 30, 2019

Last Update Submit

May 8, 2024

Conditions

Spinal Cord Neoplasm

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Diagnostic (18F-FDG PET-MRI)

EXPERIMENTAL

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-18Device: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Fludeoxyglucose F-18DRUG

Given IV

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Diagnostic (18F-FDG PET-MRI)
Magnetic Resonance ImagingDEVICE

Undergo PET-MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (18F-FDG PET-MRI)
Positron Emission TomographyPROCEDURE

Undergo PET-MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (18F-FDG PET-MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Fluorodeoxyglucose F18Magnetic Resonance ImagingMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Maria K Gule-Monroe

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 7, 2020

Study Start

September 21, 2018

Primary Completion

May 7, 2024

Study Completion

May 7, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

US(1)