PET/MRI Imaging for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method to assist doctors in placing catheters in the brains of patients with malignant gliomas, a type of brain tumor. It combines PET and MRI scans with two investigational drugs, including [18F]FMISO (a radiotracer used in PET scans), to determine if this method enhances treatment accuracy. This trial is for individuals already enrolled in a larger brain cancer study who can undergo MRI scans without heavy sedation. As an Early Phase 1 trial, the research aims to understand how the new imaging method functions in people, offering participants an opportunity to contribute to groundbreaking advancements in brain cancer treatment.
What prior data suggests that this imaging approach is safe for brain tumor patients?
Research has shown that [18F]FMISO, a drug used in PET scans, has been tested in studies with brain tumor patients to understand tumor characteristics. However, detailed information on its safety in humans remains limited. As a result, the potential side effects and tolerability are not well understood. This trial is in an early phase, focusing primarily on assessing safety. At this stage, researchers closely monitor any potential risks to ensure participant safety.12345
Why are researchers excited about this trial?
Researchers are excited about the PET/MRI imaging technique using [18F]FMISO for brain tumors because it offers a unique way to visualize tumor hypoxia, which is an area of low oxygen within tumors. Unlike traditional imaging methods, this technique provides detailed insights into the tumor's environment, potentially leading to more personalized treatment plans. The use of [18F]FMISO, a radiotracer, allows doctors to see how extensive the hypoxic regions are, which is critical since these areas are often more resistant to conventional therapies like radiation. This advanced imaging method could help refine treatment strategies and improve outcomes for patients with gliomas.
What evidence suggests that this imaging approach is effective for guiding catheter placement in malignant gliomas?
Research has shown that [18F]FMISO PET imaging, which participants in this trial will undergo, can assess brain tumors by revealing their oxygen levels. This is crucial because tumors with lower oxygen levels might not respond well to treatments like radiation and chemotherapy. Studies have found that [18F]FMISO provides valuable information about low oxygen levels in tumors, aiding in predicting treatment response. Additionally, [18F]FMISO has proven useful in understanding tumor characteristics, offering a clearer picture for treatment planning. These findings suggest that [18F]FMISO PET could be a promising tool for understanding and managing gliomas.23456
Who Is on the Research Team?
Anna Sorace, PhD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for adults with malignant brain tumors like glioblastoma, grade 3 or 4 astrocytoma, or gliosarcoma who are already enrolled in a related main study. Participants must be able to undergo PET/MRI scans and neurosurgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging
Participants undergo baseline PET/MRI imaging using [18F]FET and [18F]FMISO to guide catheter placement
Post-Surgery Follow-up Imaging
Participants undergo follow-up FET-PET/MRI imaging at approximately 1 month, 3 months, and 6-8 months post-surgery
Clinical Follow-up
The study team continues to follow participants' health through regular clinic visits and imaging as directed under the main study
What Are the Treatments Tested in This Trial?
Interventions
- [18F]FMISO
Trial Overview
The study tests new imaging methods using two special PET scan drugs ([18F]FET and [18F]FMISO) along with MRI to help doctors better place catheters during brain tumor surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
FET and FMISO PET/MRI studies will be performed on either 1) same day or 2) separate days within 14 days of each other. Baseline imaging will occur within 21 days before surgery. Every effort will be made to perform these studies within 1 week of each other. FMISO-PET/MRI will be administered first with a four-hour uptake time followed by a dynamic FET-PET/MRI (\<90 min total scan time). For separate scans, FET-PET/MRI will typically be performed first although the order can be switched if needed due to PET tracer production or scanner scheduling. Patients will fast for at least 4 hours prior to FET administration and will undergo dynamic scans. No fasting or other special preparation is required for FMISO studies and imaging will be acquired after a four-hour uptake time. Additional post-surgical FET-PET/MRI scans at 1, 3 and 6 months post will follow the same steps as the separately acquired scans except no additional FMISO-PET/MRI will be performed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Citations
FMISO Imaging for Brain Cancer
The trial tests how well FMISO works with PET/MRI scans in assessing malignant brain tumors by showing oxygen levels within the tumor. This may help understand ...
Usefulness of FMISO—PET for Glioma Analysis - PMC - NIH
18F-fluorodeoxyglucose (FDG) PET is the most common tracer for predicting prognosis and differentiating other malignant brain tumors. FMISO has been suggested ...
Investigational Scans ([18F]FET and [18F]FMISO PET/MRIs ...
Many studies have shown [18F]FET is effective for imaging high grade glioma, but its usefulness soon after completing of radiation therapy is not known.
Role of [18F]FMISO PET Imaging for the Evaluation ...
[18F]FMISO PET may have relevant clinical implications in glioma assessment and management, including improved tumor characterization,
Assessment of Primary and Metastatic Brain Tumor ...
This preliminary/exploratory clinical study will investigate [F-18]FMISO in 30 evaluable patients with newly diagnosed primary brain tumor or brain metastasis.
[18F]-fluoromisonidazole (FMISO) PET/MRI hypoxic fraction ...
Two with recurrent tumor demonstrated a mean hypoxic fraction of 131 ± 66%. Our results, supported by histopathology, suggest that the noninvasive assessment of ...
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