PET/MRI Imaging for Brain Tumor

SE
Overseen BySebastian Eady
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AS

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

Participants from IRB 300007756
I am a woman who can become pregnant and have a recent negative pregnancy test.
Life expectancy greater than 12 weeks
See 3 more

Exclusion Criteria

Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
Inability to complete PET/MRI scans
Any exclusions listed in IRB 300007756
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0.5 hours
1 visit (in-person)

Baseline Imaging

Participants undergo baseline PET/MRI imaging using [18F]FET and [18F]FMISO to guide catheter placement

Up to 21 days before surgery
1 or 2 visits (in-person)

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

6-8 months
3 visits (in-person)

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

Group I: Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET/MRIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

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 ...