Molecular Imaging with MRI for Brain Cancer

Overseen By Nathalie Padron

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Inability to consent, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve brain cancer treatment by using a special MRI scan to examine gliomas, a type of brain tumor. Researchers use a 3T MRI Scanner, a high-strength magnetic resonance imaging device, to identify important tumor details without immediate surgery. This approach could aid in developing better therapies in the future. The trial seeks participants who have or might have gliomas and are already scheduled for a biopsy or surgery on their brain tumor. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to more effective brain cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI technique is safe for brain cancer patients?

Research has shown that the 3T MRI scanner is generally safe for people and is commonly used in hospitals to image various body parts, including the brain. Studies have found that the 3T MRI is more sensitive than the 1.5T MRI, allowing it to detect brain issues more clearly.

The 3T MRI has been used on many patients without major safety problems. For instance, a child with a cochlear implant safely underwent a 3T MRI brain scan, demonstrating its tolerance in various situations. Overall, the 3T MRI is widely used and known for its reliability in medical imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a 3T MRI scanner for brain cancer because it offers more detailed images of the brain compared to standard MRI machines. This advanced imaging helps doctors better identify and understand gliomas, particularly in IDH-mutant glioma patients. By providing clearer, more precise images, the 3T MRI can potentially improve diagnosis and treatment planning, which could lead to more effective and personalized care for patients with brain tumors.

What evidence suggests that this MRI technique is effective for brain cancer?

Research has shown that the 3T MRI Scanner detects brain lesions more effectively than the older 1.5T MRI. This advanced MRI provides detailed images that assist doctors in creating personalized treatment plans for brain cancer. In this trial, patients with suspected or confirmed gliomas will undergo a 3T MRI scan, which can also predict changes in certain genes, such as IDH mutations, in gliomas. The 3T MRI employs a special technique called APT-weighted imaging, which shows promise in accurately diagnosing and monitoring these tumors. Overall, the 3T MRI offers a clearer view of brain tumors, aiding doctors in planning better treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Macarena De La Fuente, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected or confirmed gliomas who are scheduled for a medically indicated brain biopsy or resection. It's not suitable for those unable to consent, minors, pregnant women, or patients who can't undergo MRI scans.

Inclusion Criteria

I am scheduled for a biopsy or surgery to remove a brain lesion.

Exclusion Criteria

I am unable to give consent for myself.

You are unable to have an MRI scan.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo a 3 Tesla (3T) Magnetic Resonance Imaging (MRI) scan of their brain

1 day

1 visit (in-person)

Surgical Procedure

Participants undergo biopsy or resection of their brain tumors for tissue sample collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3T MRI Scanner

Trial Overview The study uses a high-tech MRI scanner to non-invasively measure the distribution of a specific molecule (2HG) and cell density in brain tumors. This could help in developing new treatments for gliomas.

How Is the Trial Designed?

Group I: IDH-Mutant Glioma Patients Experimental Treatment 1 Intervention

Patients who have suspected or confirmed gliomas and are scheduled to undergo biopsy or resection of their brain tumors will receive a 3 Tesla (3T) Magnetic Resonance Imaging (MRI) scan of their brain.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The study developed a targeted imaging strategy using F(ab')2 fragments of an anti-EGFRvIII antibody linked to enzymes, which successfully enhanced MRI signal detection of aggressive brain tumors overexpressing the EGFRvIII variant.

Using SPECT/CT and 3T MRI, the researchers demonstrated that this method allows for high specificity and resolution in imaging tumor-specific receptors, indicating its potential for improved diagnosis and monitoring of brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR signal amplification for imaging of the mutant EGF receptor in orthotopic human glioma model. Shazeeb, MS., Gupta, S., Bogdanov, A.[2021]

Clinical magnetic resonance imaging (cMRI) can effectively be used to image mouse brains, achieving high resolutions of up to 120 x 120 micrometers, which is crucial for neuroscience research.

This method allows for accurate measurement of tumor volumes in mouse models, showing a strong correlation with histological analysis, and enables monitoring of treatment effects, such as external field irradiation in glioma models, without the need for expensive specialized equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of mouse brain using a clinical 1.5 T scanner and a standard small loop surface coil. Brockmann, MA., Ulmer, S., Leppert, J., et al.[2006]

Using a clinical 3T MRI scanner with a dedicated RF coil, researchers successfully characterized neuroblastoma tumors in transgenic mice, showing excellent image quality and significant correlations with data from a 7T MRI system.

The study demonstrated that cyclophosphamide significantly reduced tumor burden and altered MRI biomarkers, while cabozantinib delayed tumor growth, highlighting the potential of multiparametric MRI to evaluate treatment efficacy in pre-clinical models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-clinical imaging of transgenic mouse models of neuroblastoma using a dedicated 3-element solenoid coil on a clinical 3T platform. Almeida, GS., Panek, R., Hallsworth, A., et al.[2019]

Molecular imaging, particularly using MRI, allows for the early detection of biological abnormalities associated with diseases before any physical changes are visible, enhancing diagnostic capabilities.

Current research is focused on improving MRI techniques with specific contrast agents to better visualize various biological processes, such as stem cell activity and apoptosis, which could lead to more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography: potentials of molecular imaging]. Hiller, KH., Faber, C., Neuberger, T., et al.[2019]

MRI is a powerful tool in oncology that not only provides detailed anatomical images but also offers functional imaging capabilities to visualize and quantify biochemical processes in tumors.

Recent advancements in MRI technology can enhance the evaluation of cancerous lesions and allow for noninvasive guidance and monitoring of anticancer therapies, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer imaging: novel concepts in clinical magnetic resonance imaging. Kwee, TC., Takahara, T., Klomp, DW., et al.[2010]

Dynamic susceptibility contrast perfusion MRI (DSC-MRI) can effectively differentiate glioma molecular profiles, showing significant differences in cerebral blood volume (CBV) measurements based on IDH1/2 mutation and ATRX expression in 100 patients with confirmed gliomas.

The study found that while DSC-MRI can predict molecular subgroups in astroglial tumors with 76.3% accuracy, its diagnostic performance drops to 48.1% when including oligodendrogliomas, indicating challenges in accurately classifying these tumors due to overlapping rCBV values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Molecular Profiling of Human Glioma : Cross-Sectional Observational Study Using Dynamic Susceptibility Contrast Magnetic Resonance Perfusion Imaging. Hempel, JM., Schittenhelm, J., Klose, U., et al.[2022]

This study successfully utilized a standard clinical 1.5 T MR scanner to perform advanced imaging techniques on a rat glioma model, demonstrating that conventional equipment can effectively assess tumor characteristics without the need for specialized animal scanners.

The results showed that the mean transit time of a contrast agent was significantly slower in the tumor compared to healthy brain tissue, indicating disrupted blood-brain barrier function, which is crucial for understanding tumor biology and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced susceptibility-weighted perfusion MRI (DSC-MRI) in a glioma model of the rat brain using a conventional receive-only surface coil with a inner diameter of 47 mm at a clinical 1.5 T scanner. Ulmer, S., Reeh, M., Krause, J., et al.[2008]

This study successfully demonstrated that high-resolution MRI images of brain tumors in rats can be obtained using a standard clinical 1.5 T MR scanner, making it a more accessible option for studying tumor growth and treatment effects.

The MRI findings correlated well with histological analyses, confirming the effectiveness of this imaging technique in accurately assessing tumor volumes and characteristics, which could be applied to other tumor models in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of experimental rat gliomas using a clinical MR scanner. Thorsen, F., Ersland, L., Nordli, H., et al.[2019]

High-field MRI significantly enhances the visualization of tumor structures and vasculature, improving the detection of cerebral metastases and potentially aiding in the monitoring of antiangiogenic therapies.

The introduction of advanced imaging techniques, such as susceptibility-weighted imaging (SWI) and sodium imaging, allows for deeper insights into tumor pathophysiology, which could lead to better treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of ultrahigh-field MRI in neuro-oncology]. Radbruch, A., Schlemmer, HP.[2021]

The study demonstrated that MRI-coupled fluorescence molecular tomography (FMT) can accurately determine epidermal growth factor receptor (EGFR) status in brain cancer, achieving 100% sensitivity and specificity in distinguishing between tumors with high and low EGFR expression in a preclinical model involving nude mice.

This innovative imaging technique allows for reliable quantification of receptor status in a minimally invasive manner, which could significantly enhance the investigation of targeted cancer treatments and potentially be applied to human brain cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-coupled fluorescence tomography quantifies EGFR activity in brain tumors. Davis, SC., Samkoe, KS., O'Hara, JA., et al.[2021]

Animal brain tumor models have significantly advanced our understanding of tumor biology and the effectiveness of new treatments over the past 25 years.

The use of MRI and MRS as noninvasive tools allows for detailed monitoring of tumor growth and treatment responses in these models, enhancing the evaluation of novel therapies like gene transfer technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging and Spectroscopy: Application to Experimental Neuro-Oncology. Ross, BD., Chenevert, TL., Kim, B., et al.[2020]

The Glioma MR Imaging 2.0 (GliMR) network aims to enhance the use of advanced MRI techniques in glioma treatment, addressing the current limitations in clinical practice and promoting personalized treatment strategies.

Funded by the European Cooperation in Science and Technology, GliMR has initiated several projects to improve glioma imaging, including developing GDPR-compliant consent forms and creating a collaborative platform for experts, with ongoing membership opportunities until September 2023.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GliMR: Cross-Border Collaborations to Promote Advanced MRI Biomarkers for Glioma. Clement, P., Booth, T., Borovečki, F., et al.[2022]

Molecular imaging using magnetic resonance techniques allows for the detection of specific biomolecules and molecular changes in cancer, which is crucial for effective treatment and monitoring of therapeutic outcomes.

The integration of molecular MR with other imaging methods can lead to personalized treatment strategies, potentially improving overall cancer care and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular magnetic resonance imaging in cancer. Haris, M., Yadav, SK., Rizwan, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4483120/

Imaging of gliomas at 1.5 and 3 Tesla - A comparative study Studies have shown that 3T MR is more sensitive than 1.5T MR for detecting brain lesions. If the magnetic field has an impact on the measured tumor size or the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5561497/

Predicting IDH mutation status in grade-II gliomas using ... Based on the multi-ROI analysis, the IDH-wildtype gliomas had higher maximum (2.03 ± 0.72 vs. 0.99 ± 0.33) and minimum (0.99 ± 0.47 vs. 0.59 ± 0.32) APTw values ...

3. withpower.com withpower.com/trial/phase-glioma-2019-0b436

Molecular Imaging with MRI for Brain Cancer Research shows that advanced MRI, like the 3T MRI Scanner, can help doctors make personalized treatment decisions for brain cancer by providing detailed images ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jmri.29561

Assessment the Impact of IDH Mutation Status on MRI ... Despite advances in treatment, the prognosis for glioma patients remains poor, with a median survival of 15 months. Among genetic markers, ...

5. nature.com nature.com/articles/s41598-023-44891-0

Reproducibility of APT-weighted CEST-MRI at 3T in ... APT-weighted CEST has shown great potential for clinical glioma imaging, including predicting IDH mutation status for diagnosis, response ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03684109

Study Details | NCT03684109 | Non-invasive Glioma ... Patients who have suspected or confirmed gliomas and are scheduled to undergo biopsy or resection of their brain tumors will receive a 3 Tesla (3T) Magnetic ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587620301580

Case Report 3 Tesla MRI brain scanning under general ... This is the first reported case of a child with a 3 Tesla-compatible cochlear implant undergoing a 3 Tesla MRI scan of the brain under general anaesthesia.

8. ajnr.org ajnr.org/content/early/2024/12/20/ajnr.A8432

IDH Status in Brain Gliomas Can Be Predicted by the ... Patients with histologically confirmed adult-type diffuse glioma underwent a multiparametric MRI examination using a 3T system, which included a ...