MRI for Brain Tumor

Overseen By Study Nurse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Cognition-enhancing, Blood thinners

Disqualifiers: Dementia, Cognitive impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if brain scans and blood tests can predict changes in memory or attention following radiation treatment for brain tumors. Researchers seek to identify whether these tests can pinpoint individuals likely to experience significant changes in brain function. The trial includes PET and MRI brain scans, a blood draw, and a memory test. Individuals with high-grade glioma, a type of brain tumor, who are about to begin six weeks of combined chemotherapy and radiation, may be suitable candidates. Participants should not have severe cognitive impairments or be taking medications that enhance cognition. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve future brain tumor treatments.

Will I have to stop taking my current medications?

If you are currently taking cognition-enhancing medications like Donepezil, Memantine, Armodafinil, or Methylphenidate, you will need to stop taking them to participate in this trial. If you are on blood thinners, you can still join the main study but cannot participate in the optional lumbar puncture.

What prior data suggests that this protocol is safe for brain tumor patients?

Research has shown that PET-MRI is a promising tool for studying brain tumors, providing detailed images that enhance doctors' understanding. This combination of PET and MRI aids in both diagnosing and managing brain conditions.

Regarding safety, studies have examined the use of PET-MRI with the tracer 18F-fluciclovine in patients with severe brain tumors. These studies found it safe for managing brain tumors in children, indicating it is well-tolerated.

While the trial under consideration focuses on changes in brain function after radiation, studies have not identified major safety concerns with PET-MRI. This is important to consider when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

This trial focuses on using PET-MRI scans to better understand high-grade gliomas, a type of aggressive brain tumor. Researchers are excited about this trial because combining PET and MRI scans offers a more detailed picture of the tumor's structure and activity than standard MRI or CT scans alone. This comprehensive imaging approach could lead to more accurate assessments of how the tumor is responding to chemoradiation, potentially improving personalized treatment plans. Additionally, by including memory testing and blood draws, researchers hope to gather valuable data on how these tumors and their treatments affect brain function and overall health.

What evidence suggests that this trial's methods could be effective for predicting brain function changes after radiation?

Research has shown that using both PET and MRI scans together can improve the diagnosis of brain tumors, such as high-grade gliomas. In this trial, participants will undergo PET-MRI scans, which studies have found to be slightly more effective at identifying these tumors than PET/CT scans. This combined method helps doctors see the tumor more clearly and might predict changes in brain function after treatments like radiation. PET scans use a special dye to show how organs function, while MRIs use magnets and radio waves to create detailed brain images. By combining these scans, doctors can gain a clearer view of brain activity, which is crucial for planning treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Christina Cramer, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high-grade glioma (grade III or IV) or specific grade II glioma, who are about to undergo 6 weeks of chemoradiation. They should be able to perform daily activities with varying degrees of assistance and must not have dementia, cognitive impairments before their tumor diagnosis, or be on cognition-enhancing drugs. Pregnant women and those unable to consent or fast before procedures are excluded.

Inclusion Criteria

I am expected to undergo 6 weeks of combined chemotherapy and radiation treatment.

My brain tumor is a high grade (III or IV) or a specific type of grade II.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

Pregnant or nursing mothers

I am unable to understand and agree to the study's details on my own.

I was diagnosed with dementia or mild cognitive impairment before my brain tumor diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Participants undergo chemoradiation treatment, including PET scans, MRI scans, blood draws, and memory testing

4 months

Follow-up

Participants are monitored for cognitive decline and changes in biomarkers post-treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• N/A

Trial Overview The study aims to predict changes in brain function after radiation therapy using PET-MRI scans, blood tests, memory testing, and optional lumbar punctures. Researchers want to see if these methods can forecast who will experience significant declines in memory or attention due to the treatment.

How Is the Trial Designed?

Group I: PET-MRI In High-Grade Glioma Patients Undergoing Chemoradiation Experimental Treatment 4 Interventions

PET scan and MRI scan of the brain, blood draw, and 1-hour of memory testing.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

MRI is a safe, noninvasive imaging technique that effectively visualizes intracranial anatomy and is particularly sensitive in detecting brain tumors without using ionizing radiation or contrast agents.

While MRI excels at showing the extent of intracranial tumors, its specificity for different tumor types remains uncertain, highlighting the need for further research to optimize its diagnostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the evaluation of intracranial tumors of childhood. Packer, RJ., Batnitzky, S., Cohen, ME.[2019]

Intraoperative magnetic resonance (MR) imaging significantly aided in achieving complete tumor resection, with 80% of patients showing radiologically complete resections based on intraoperative findings.

The use of MR imaging during surgery was safe, with a low frequency of complications and no adverse effects related to the MR environment, highlighting its potential benefits in brain tumor surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain tumor resection: intraoperative monitoring with high-field-strength MR imaging-initial results. Martin, AJ., Hall, WA., Liu, H., et al.[2004]

Brain tumors, particularly glioblastoma, have a very low 5-year survival rate, highlighting the need for better detection methods; glioblastoma has a survival rate of only 4.7%.

Magnetic resonance imaging (MRI) screening in asymptomatic adults can identify early gliomas and benign brain abnormalities, but further research is necessary to evaluate if this screening can actually reduce morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-Based Screening for Asymptomatic Brain Tumors: A Review. Neugut, AI., Sackstein, P., Hillyer, GC., et al.[2020]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

MRI is the preferred imaging technique for evaluating primary brain tumors due to its high resolution, quick acquisition time, and excellent safety profile for patients.

The article emphasizes the importance of accurately interpreting MRI results to assess treatment response and guide therapeutic decisions in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of MRI in primary brain tumor evaluation. Leung, D., Han, X., Mikkelsen, T., et al.[2019]

A magnetic resonance imaging (MRI) quality assurance program across 11 sites in the Pediatric Brain Tumor Consortium showed that quantitative imaging metrics generally met the American College of Radiology (ACR) guidelines, indicating effective monitoring of imaging quality.

The study revealed that intersite variability in critical imaging parameters, such as slice thickness and geometric accuracy, was relatively low (around 10% and 1%, respectively), suggesting that the QA program can help ensure consistent and reliable imaging for assessing brain tumor responses in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment and results of a magnetic resonance quality assurance program for the pediatric brain tumor consortium. Mulkern, RV., Forbes, P., Dewey, K., et al.[2021]

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

Magnetic resonance imaging (MRI) has become essential for diagnosing and monitoring brain tumors, with volumetric growth being a key prognostic indicator.

Advanced MRI techniques, such as perfusion-weighted imaging and diffusion tensor imaging, enhance the sensitivity and specificity of brain tumor assessments, improving characterization, grading, and treatment management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multimodal magnetic resonance imaging of brain tumors]. Guillevin, R., Menuel, C., Vallée, JN.[2011]

The study found a positive correlation between the frequency of cerebral MRI scans and the incidence rates of intracranial tumors in Norway, suggesting that increased MRI use may lead to more diagnoses of brain tumors, particularly benign extraaxial tumors.

While higher rates of MRI scans were associated with longer overall survival for patients with intracranial tumors, this association lost statistical significance when accounting for other factors, indicating that the relationship may not be straightforward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cerebral magnetic resonance imaging in outpatients on observed incidence of intracranial tumors and patient survival: a national observational study. Solheim, O., Torsteinsen, M., Johannesen, TB., et al.[2022]

In a study of 189 patients undergoing MR imaging for brain or spine evaluation, 16% had their suspected diagnosis refined or changed based on the imaging results.

The MR imaging significantly impacted treatment decisions and prognosis estimates, with two-thirds of physicians reporting changes in treatment plans or prognosis after reviewing the MR images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of MR imaging on clinical diagnosis and management: a prospective study. Franken, EA., Berbaum, KS., Dunn, V., et al.[2015]

In a study involving 103 medical and neurologic inpatients, 89% of physicians found that MR imaging significantly enhanced diagnostic information, aiding in diagnosis, treatment planning, and prognosis estimation.

MR imaging was particularly beneficial in cases of diagnostic uncertainty, as it more often decreased confidence in incorrect presumptive diagnoses rather than increasing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical assessment of MR of the brain in nonsurgical inpatients. Hirsch, JA., Langlotz, CP., Lee, J., et al.[2021]

In a study of 863 patients undergoing MRI with gadodiamide contrast, only 9 reported mild adverse events, all of which were from the group that was actively questioned about their experiences after the injection.

The results suggest that the frequency of reported adverse events is influenced by whether patients are actively asked about them, indicating that many mild reactions may go unreported without such inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. Thomsen, HS.[2019]

MRI is superior to CT for imaging brain tumors due to its ability to provide high tissue contrast and visualize in multiple planes, enhancing the detection of extraaxial tumors with the use of paramagnetic contrast agents.

Despite its high sensitivity for detecting intracranial tumors, MRI's specificity is not significantly better than CT, and definitive diagnosis of conditions like high-grade glioma, abscess, and metastasis still requires biopsy, indicating a need for further advancements in tissue characterization methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of cerebral tumors: state of the art and work in progress. Higer, HP., Pedrosa, P., Schuth, M.[2019]

MRI is the primary method for diagnosing brain tumors, utilizing differences in water properties between normal and tumor tissues to create contrast in images, which helps in distinguishing tumors from healthy tissue.

Magnetic resonance spectroscopy (MRS) complements MRI by analyzing tissue metabolites, providing additional biochemical information that aids in characterizing brain tumors, including their type and grade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI and MRS of human brain tumors. Hou, BL., Hu, J.[2013]

Citations

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18F-Fluciclovine PET-MRI in High-grade Glioma The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas.

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Impact of 18F-FET PET/MRI on Clinical Management of Brain ... Our results suggest that 18 F-FET PET/MRI helps clarify equivocal conditions and profoundly supports the clinical management of brain tumor patients.