Dual Time Point FDG PET/MRI Scan in Improving the Imaging Cancer Patients With Brain Metastases

NCT ID: NCT05054998

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2024-04-26

Brief Summary

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This phase IV trial studies how well delaying positron emission tomography (PET)/magnetic resonance imaging (MRI) scan after injection of fluorodeoxyglucose (FDG) can improve the imaging of patients with cancer that has spread to brain (brain metastases). FDG is a type of imaging agent that doctors use to help "see" the images on a scan more clearly. Delaying PET/MRI scan after injecting FDG may improve how well doctors can tell the difference between healthy and unhealthy tissue.

Detailed Description

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PRIMARY OBJECTIVE:

I. To assess the optimal fludeoxyglucose F-18 (fluorodeoxyglucose) positron emission tomography (FDG 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 brain metastasis.

SECONDARY OBJECTIVE:

I. To identify genotypic factors in FDG tumor metabolism derived from metrics, including 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, and 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.

II. To identify if post treatment changes in lesion metabolism from baseline correlate with treatment success.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.

Conditions

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Metastatic Malignant Neoplasm in the Brain Metastatic Malignant Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (fludeoxyglucose F-18, PET/MRI)

Patients receive fludeoxyglucose F-18 IV over approximately 1 minute and undergo a PET/MRI scan over 70 minutes. Within 5 hours of receiving fludeoxyglucose F-18, patients undergo a repeat PET/MRI scan over 30 minutes. Scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.

Group Type EXPERIMENTAL

Fludeoxyglucose F-18

Intervention Type RADIATION

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/MRI

Interventions

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Fludeoxyglucose F-18

Given IV

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

Intervention Type PROCEDURE

Other Intervention Names

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18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Pre-treatment adult patients with any solid organ metastasis and at least three intraaxial brain metastases including at least one enhancing \> 10 mm lesion
* Rim or solid enhancing lesion(s) WITH a history of non-central nervous system (CNS) pathologic proven metastatic disease will be considered as a consensus between the referring radiation oncologist or neurosurgeon and a neuroradiology
* Planned surgery or radiation to the metastases
* Ability to undergo PET magnetic resonance (MR) examination

Exclusion Criteria

* Known allergy to FDG or gadolinium based contrast agents
* History of impaired renal function (glomerular filtration rate \[GFR\] \< 30)
* Pregnant women are excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dawid Schellingerhout

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center

Other Identifiers

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NCI-2019-02459

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0435

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0435

Identifier Type: -

Identifier Source: org_study_id

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