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

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ClinicalTrials.gov Identifier: NCT05054998
Recruitment Status : Recruiting
First Posted : September 23, 2021
Last Update Posted : September 23, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 3, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: through study completion, an average of a year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054998


Contacts
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Contact: Jason Johnson 713-792-8443 jcjohnson@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jason Johnson    713-792-8443      
Principal Investigator: Jason Johnson         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jason M Johnson M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05054998    
Other Study ID Numbers: 2017-0435
NCI-2019-02459 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0435 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Deoxyglucose
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents