FDG PET Imaging in Diagnosing Patients With Glioblastoma

Brain Glioblastoma Clinical Trial

Official title:

Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885272
• Other study ID #: 2016-0261
• Secondary ID: NCI-2016-0197120
• Status: Completed
• Phase: Early Phase 1
• Start date: October 28, 2016
• Est. completion date: July 12, 2022

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This early phase I trial studies the how well fluorodeoxyglucose F-18 (FDG) positron emission tomography (PET) imaging works in diagnosing patients with confirmed or suspected glioblastoma. Diagnostic procedures, such as FDG PET, may help find and diagnose glioblastoma.

Description:

PRIMARY OBJECTIVES:

I. To assess the optimal FDG positron emission tomography (PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with glioblastoma.

SECONDARY OBJECTIVES:

I. To identify genotypic factors in FDG tumor metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV) and L/B ratio.

EXPLORATORY OBJECTIVES:

I. 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, fractional diffusivity measures and magnetic resonance spectroscopic finding.

OUTLINE:

Patients receive fluorodeoxyglucose F-18 intravenously (IV) over 1 minute and then undergo PET/computed tomography (CT) scans over 30 minutes at 1 hour, 4-5 hours, and 7-8 hours after injection. Patients also undergo a standard of care magnetic resonance imaging (MRI) scan over 45 minutes if not already completed as part of standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult (> 19 years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain

• Cases without prior biopsy will be chosen based upon consensus of a MD Anderson faculty neuroradiologist and neurosurgeon for high probability of representing a glioblastoma

• T1 post contrast lesion size greater than or equal to 10 mm

Exclusion Criteria:

• Children

• Definitive/gross total lesion resection

• Prior brain cancer

• Prior whole brain radiation

• Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury

• Known allergy to FDG or gadolinium based contrast agents

• Pregnant women are excluded

Related Conditions & MeSH terms

• Brain Glioblastoma
• Glioblastoma

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scans

Radiation:
• Fludeoxyglucose F-18
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo standard of care MRI
• Positron Emission Tomography
Undergo PET/CT scans

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	Differences in length-beam ratio	Will be tested via paired t-test after appropriate transformation.	Up to 2 years
Primary	Quantitative parametric maps based on biophysical principles or pharmacokinetic modeling	Will be derived from magnetic resonance advanced brain tumor imaging.	Up to 2 years
Primary	Magnetic resonance images of relative blood volume, blood flow, apparent diffusion coefficient and forward volumetric transfer constant	Will be used to derive quantitative parametric maps based on biophysical principles or pharmacokinetic modeling.	Up to 2 years
Primary	Fluorodeoxyglucose F-18 uptake patterns	Will be correlated with magnetic resonance images.	Up to 2 years
Primary	Genotypic factors	Will be assessed via two-sample t-tests, for all genes of interest with at least 20% of mutation prevalence.	Up to 2 years

External Links

•   University of Texas MD Anderson Cancer Center Website