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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05054998
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 40.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm	Radiation: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography	Phase 4

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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:

1. 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.

2. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study of Dual Time Point FDG PET MR Imaging Optimization for the Evaluation of Brain Metastasis
• Actual Study Start Date: Aug 3, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

1. 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 [through study completion, an average of a year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jason M Johnson, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05054998
• Other Study ID Numbers: 2017-0435; NCI-2019-02459; 2017-0435
• First Posted: Sep 23, 2021
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Brain Neoplasms; Deoxyglucose; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Sep 23, 2021