Advanced Imaging for Brain Cancer

Overseen By Dawid Schellingerhout, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Renal failure, Pacemakers, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether advanced imaging methods, such as MRI (Magnetic Resonance Imaging) and CT (Computed Tomography) scans, can distinguish between actual and apparent signs of brain cancer progression. The goal is to determine if the disease is truly worsening or if it merely appears so on the scans. Individuals who have undergone previous treatment for a brain tumor and require a biopsy due to new suspicious findings may find this trial suitable. Participants will undergo scans shortly before their biopsy to provide doctors with accurate images. As a Phase 1 trial, the research focuses on understanding how these imaging methods function in people, offering participants the opportunity to contribute to groundbreaking advancements in brain cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these advanced imaging methods are safe for brain cancer patients?

A previous study showed that MRI scans are generally safe. They do not use ionizing radiation, which can be harmful. However, because they use strong magnets, individuals with metal in their bodies need to exercise caution.

In contrast, CT scans use a small amount of radiation, which is usually controlled to ensure safety. Nonetheless, there is a slight risk that this radiation could lead to cancer over many years.

Both MRI and CT scans are common tools in medicine, frequently used to help doctors see inside the body without surgery. Most people tolerate these scans well, but discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of advanced imaging techniques, like MRI and CT scans, to enhance brain cancer treatment. Unlike standard imaging, which typically happens just before surgery, this approach involves detailed scans up to two weeks prior. By providing surgeons with more precise images ahead of time, this method could improve surgical outcomes and better inform treatment plans. This proactive imaging strategy aims to deliver clearer insights into the tumor's characteristics, potentially leading to more effective interventions.

What evidence suggests that these advanced imaging methods are effective for distinguishing true progression from pseudoprogression in brain cancer?

In this trial, participants will undergo advanced MRI and CT scans as part of their standard-of-care biopsy preparation. Research has shown that MRI scans excel at detecting brain tumors. One study used a special computer program that was 97.5% accurate in identifying brain tumors in MRI images. This accuracy helps distinguish between actual tumor growth and changes that merely resemble growth. CT scans are also commonly used to check brain issues, but they involve radiation, which carries some risk. While both MRI and CT scans are useful for examining brain tumors, MRI is particularly promising due to its precision in tumor detection. ^{1 4 5 6 7}

Who Is on the Research Team?

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with brain tumors who may be experiencing either true progression or pseudoprogression. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a diagnosis relevant to the study.

Inclusion Criteria

The participants agrees to participate in the clinical study and to complete all required visits and evaluations.

I had treatment for a brain tumor and now have new concerning brain scans.

Participants agrees to undergo, prior to the procedure, the needed imaging evaluation (within 14 days and preferably with 3 days of the planned procedure).

Exclusion Criteria

Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: electronically, magnetically, and mechanically activated implants, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers, metallic splinters in the eye, ferromagnetic hemostatic clips in the central nervous system (CNS) or body, cochlear implants, other pacemakers, e.g., for the carotid sinus, insulin pumps and nerve stimulators, non-MR safe lead wires, prosthetic heart valves (if dehiscence is suspected), non-ferromagnetic stapedial implants, pregnancy, claustrophobia that does not readily respond to oral medication.

My kidney function is low, with a GFR under 30, or my doctor isn't concerned about my kidney history for this test.

My kidney function is suitable for certain types of CT scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy Preparation

Participants undergo advanced MRI and CT scans as part of standard-of-care biopsy preparation

2 weeks

1-2 visits (in-person)

Biopsy and Imaging Correlation

Stereotactic biopsy is performed and imaging findings are correlated with pathology to distinguish true progression from pseudoprogression

1-2 weeks

Follow-up

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

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Biopsy
• CT Scan
• MRI Scan

Trial Overview The trial is testing whether advanced MRI and CT scans, along with biopsies when necessary, can accurately differentiate between actual tumor growth (true progression) and false signs of tumor growth (pseudoprogression).

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 3 Interventions

The tests and procedures done as part of your standard-of-care biopsy preparation, participants will also have advanced MRI and CT scans performed no later than 2 weeks before the biopsy. Typically, these scans are done within 1 or 2 days before surgery to provide the most accurate images to the surgeon.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Advanced MRI techniques, such as diffusion-weighted imaging and perfusion-weighted imaging, enhance the assessment of brain tumors by providing critical information on tumor characteristics like cellularity and blood volume, which are not visible with conventional MRI methods.

These advanced imaging techniques are valuable for clinical neurologists in differentiating tumor types, determining tumor grades, planning surgeries, and monitoring how well treatments are working.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced MRI of adult brain tumors. Young, GS.[2022]

Standard MRI techniques, like T1-weighted and T2-weighted imaging, are essential for diagnosing brain tumors but do not fully capture the tumor's biological behavior and response to treatment.

Advanced MRI methods can provide deeper insights into tumor metabolism and blood flow, potentially leading to better assessment and management of neuro-oncologic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Advanced Brain Tumor Imaging in the Care of Patients with Central Nervous System Malignancies. Ly, KI., Gerstner, ER.[2019]

Functional imaging techniques, such as MRI and PET, are highly promising for improving the detection, grading, and treatment planning of brain tumors in neuro-oncology.

Despite their potential, the widespread clinical use of these advanced imaging methods is hindered by high costs and challenges in validating their effectiveness across multiple clinical trial sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Tumor Imaging. Brindle, KM., Izquierdo-García, JL., Lewis, DY., et al.[2022]

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]

A single injection of double-dose contrast medium (0.4 mL/kg) significantly improved margin delineation of brain metastasis lesions compared to two separate injections, suggesting a more effective imaging method.

Delayed imaging after the single injection resulted in larger enhanced volumes of lesions, which could impact treatment decisions for patients with brain metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between two separate injections and a single injection of double-dose contrast medium for contrast-enhanced MR imaging of metastatic brain tumors. Ochi, T., Taoka, T., Matsuda, R., et al.[2015]

Advanced imaging techniques like magnetic resonance imaging (MRI) and positron emission tomography (PET) are crucial for diagnosing and monitoring brain tumors, especially as new therapies are developed.

These imaging modalities help improve diagnostic accuracy and tackle complex issues such as distinguishing between true tumor progression and pseudoprogression, as well as assessing the effectiveness of anti-angiogenic therapies and immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging in neuro-oncology. Nandu, H., Wen, PY., Huang, RY.[2020]

A systematic review of 22 studies found that amino acid PET (aaPET) is generally more effective than advanced MRI (aMRI) techniques for detecting brain tumors, predicting recurrence, and assessing patient survival.

Combining aaPET with advanced MRI methods, particularly diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI), significantly enhances diagnostic performance, making it the most effective approach for brain tumor imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Amino Acid PET to Advanced and Emerging MRI Techniques for Neurooncology Imaging: A Systematic Review of the Recent Studies. Stopa, BM., Juhász, C., Mittal, S.[2021]

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]

Advanced MRI techniques, such as diffusion-weighted imaging and MR spectroscopy, play a crucial role in evaluating brain tumors by providing detailed information about tumor characteristics and behavior.

These imaging methods enhance the ability to assess tumor type, grade, and response to treatment, improving patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced MR Imaging Techniques in Daily Practice. Mabray, MC., Cha, S.[2017]

In a study of 1185 patients undergoing MRI-informed prostate biopsies during active surveillance, key predictors for grade group reclassification included age, MRI outcomes, PSA density, and percentage of positive biopsy cores.

Patients with negative MRI results and a PSA density of less than 0.15 ng/ml cm3 can safely skip a repeat biopsy, while those with other risk factors still require careful monitoring and may need a confirmatory biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multivariable Approach Using Magnetic Resonance Imaging to Avoid a Protocol-based Prostate Biopsy in Men on Active Surveillance for Prostate Cancer-Data from the International Multicenter Prospective PRIAS Study. Luiting, HB., Remmers, S., Boevé, ER., et al.[2023]

Magnetic Resonance (MR) tomography is a safe imaging technique for children as it does not use ionizing radiation and is non-invasive, although it requires good preparation and sometimes sedation.

MR tomography is particularly valuable in neuro-pediatrics and diagnosing soft tissue diseases, showing high sensitivity in detecting conditions like bone tumors, but further studies are needed to improve understanding of its specificity for various diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nuclear magnetic resonance tomography in childhood]. Zeitler, E., Kaiser, W., Schuierer, G., et al.[2015]

Tailored magnetic resonance fingerprinting (TMRF) can rapidly provide quantitative maps (T1, T2) and qualitative images in pediatric brain tumor patients, potentially saving about 2 minutes in imaging time.

In a study of five pediatric patients, TMRF-derived T2 weighted images showed strong correlation with standard imaging methods, indicating its effectiveness in differentiating between healthy and pathological tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored magnetic resonance fingerprinting of post-operative pediatric brain tumor patients. Poojar, P., Qian, E., Jin, Z., et al.[2023]

Advanced imaging techniques like diffusion tensor imaging (DTI), perfusion-weighted imaging (PWI), and magnetic resonance spectroscopy (MRS) enhance the diagnostic capabilities for brain tumors, especially in challenging cases where conventional imaging falls short.

Combining MRS with other imaging data, such as apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) maps, significantly improves diagnostic accuracy for brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of MR Spectroscopy and Imaging of Brain Tumor. Morita, N., Harada, M., Otsuka, H., et al.[2019]

Citations

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Projected Lifetime Cancer Risks From Current Computed ... This study found that at current utilization and radiation dose levels, CT examinations in 2023 were projected to result in approximately 103 000 future ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11997853/

Projected Lifetime Cancer Risks From Current Computed ... In this risk model, the 93 million CT examinations performed in 62 million patients in 2023 were projected to result in approximately 103 000 future cancers.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10326490/

Computed tomography scan radiation and brain cancer ... This study demonstrates that 40% of brain tumors that follow CT exposures in childhood by more than 2 years are attributable to CT radiation and not due to ...

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Detection and classification of brain tumor using a hybrid ... Accurate diagnosis of brain tumors is critical in understanding the prognosis in terms of the type, growth rate, location, removal strategy, ...

5. cancer.gov cancer.gov/about-cancer/diagnosis-staging/ct-scans-fact-sheet

Computed Tomography (CT) Scans and Cancer Fact Sheet A fact sheet that describes the CT scan procedure and technology and its uses in screening, diagnosis, and treatment.

6. mayoclinic.org mayoclinic.org/tests-procedures/brain-ct-scan/about/pac-20587837

Brain CT scan In general, a brain CT scan is considered safe. It uses a low amount of radiation. And the radiation is carefully controlled to avoid ...

7. nih.gov nih.gov/news-events/nih-research-matters/radiation-ct-scans-cancer-risks

Radiation from CT scans and cancer risks Researchers have estimated cancer risks in the United States from CT scans in earlier time periods, when scans were less common but doses may have been higher.