Dual Time Point FDG PET/MRI Scan in Improving the Imaging Cancer Patients With Brain Metastases
A Pilot Study of Dual Time Point FDG PET MR Imaging Optimization for the Evaluation of Brain Metastasis
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2018
CompletedFirst Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2024
CompletedMay 1, 2024
April 1, 2024
5.7 years
September 9, 2021
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (1)
Diagnostic (fludeoxyglucose F-18, PET/MRI)
EXPERIMENTALPatients 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.
Interventions
Given IV
Undergo PET/MRI
Undergo PET/MRI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known allergy to FDG or gadolinium based contrast agents
- History of impaired renal function (glomerular filtration rate \[GFR\] \< 30)
- Pregnant women are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawid Schellingerhout
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
September 23, 2021
Study Start
August 3, 2018
Primary Completion
April 26, 2024
Study Completion
April 26, 2024
Last Updated
May 1, 2024
Record last verified: 2024-04