MRI for Brain Tumor Detection After Radiation

Overseen By Ivy Ricca, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Chronic kidney disease, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

101 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a specialized MRI scan (Magnetic Resonance Imaging) can differentiate between a recurring brain tumor and changes caused by previous radiation treatment. The goal is to improve diagnostic accuracy in patients who have received focused radiation for brain metastases (cancer spread to the brain) and are now experiencing new growth at the same site. Suitable candidates for this trial include those with a solid cancer that has spread to the brain and who have observed changes in the tumor area after radiation. Participants should plan to undergo surgery as part of their routine care. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance diagnostic techniques for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this MRI technique is safe for brain tumor detection?

Research has shown that MRIs (magnetic resonance imaging) are generally safe and manageable for brain scans. Studies have found that MRI serves as an important tool for checking brain tumors, including those that have spread from other parts of the body, by providing detailed images of the brain.

The MRI process does not use radiation or involve invasive procedures, but it does employ strong magnets. Most people experience no side effects, though some might feel uncomfortable in the confined space. The medical team can help manage this discomfort.

There are no known serious safety concerns with using MRI for checking brain tumors. In this study, MRI is used to better understand changes after radiation treatment, building on its established safety in diagnosing and monitoring brain conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI-based treatment response assessment maps (TRAMs) for brain tumor detection after radiation because this technique offers a more precise method for assessing changes in brain tumors post-treatment. Unlike traditional imaging methods, which may not clearly differentiate between tumor growth and treatment-related changes, TRAMs provide detailed maps that can help doctors pinpoint whether a brain lesion is recurring cancer or merely a side effect of radiation. This precision could potentially lead to more informed surgical decisions and better outcomes for patients with brain metastases.

What evidence suggests that this MRI technique is effective for detecting brain tumor recurrence after radiation?

Research shows that special MRI scans, called treatment response assessment maps (TRAMs), can distinguish between a recurring brain tumor and changes caused by radiation treatment. In this trial, participants will undergo preoperative TRAMs to assess treatment response. Studies have found that these advanced MRI techniques effectively evaluate how brain tumors react to radiation. For example, one study found that MRI can track changes in brain tumors even months after treatment. This helps doctors determine if a brain lesion results from the tumor returning or merely changes from radiation. Using TRAMs could assist doctors in deciding if more treatment is needed. ^{6 7 8 9 10}

Who Is on the Research Team?

Ayal Aizer, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with confirmed extracranial solid malignancies and brain metastases previously treated with focused radiation. They must be planning neurosurgical resection as standard care, agree to use contraception, and be able to consent. Excluded are those with severe kidney disease, gadolinium allergy, pregnancy, breastfeeding or MRI contraindications.

Inclusion Criteria

I have cancer that started outside the brain but now has spread to the brain, and I've had radiation for it.

I have a growing brain lesion after radiation, needing surgery.

My cancer started outside the brain, spread there, but hasn't been biopsied outside the brain.

Exclusion Criteria

Pregnant women

I have advanced chronic kidney disease or am in end stage renal failure.

You have had a severe allergic reaction to gadolinium in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative MRIs with Treatment Response Assessment Maps (TRAMs) to delineate tumor recurrence from radiation changes

Within 3 months of study enrollment

Follow-up

Participants are monitored for safety and effectiveness after the preoperative assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study tests a specialized MRI technique to distinguish between tumor recurrence and radiation changes in the brain after stereotactic radiation therapy for brain metastases. Participants will undergo this imaging method before planned surgical removal of the lesion.

How Is the Trial Designed?

Group I: TRAMs I Experimental Treatment 1 Intervention

* Magnetic resonance imaging (MRI)-based treatment response assessment maps (TRAMs) * Patients with an enlarging lesion in the site of a brain metastasis treated with stereotactic radiation for which neurosurgical resection is planned will undergo preoperative TRAMs

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Magnetic resonance imaging (MRI) is effective in diagnosing tumor recurrence after radiation therapy for cervical cancer, with an overall accuracy of 78%, but its effectiveness improves significantly after 6 months post-treatment.

Unenhanced T2-weighted MRI images provided the best diagnostic results, while contrast enhancement was beneficial for identifying specific complications like fistula formation or recurrences in certain areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irradiation of the cervix uteri: value of unenhanced and contrast-enhanced MR imaging. Hricak, H., Swift, PS., Campos, Z., et al.[2022]

In a study of 18 patients with head and neck cancers, MRI-guided radiotherapy resulted in a high complete response rate of 83% and excellent 1-year survival rates (96% overall survival).

The treatment was safe, with no fatalities reported, although 44% of patients experienced significant acute toxicity; nonetheless, many reported improved quality of life post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided radiotherapy for head and neck cancer: initial clinical experience. Chen, AM., Hsu, S., Lamb, J., et al.[2022]

Magnetic resonance imaging (MRI) with diffusion weighted imaging can be a useful tool in differentiating between tumor recurrence and radiation-induced necrosis in patients who have been treated for brain tumors.

This case report highlights the potential of advanced imaging techniques to improve diagnostic accuracy in post-treatment brain tumor patients, which is crucial for determining the appropriate management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion weighted imaging in radiation necrosis. Biousse, V., Newman, NJ., Hunter, SB., et al.[2019]

In a study of 106 brain glioma patients, MRI images revealed distinct characteristics of high-grade gliomas (HGG) and low-grade gliomas (LGG) that can aid in planning postoperative radiotherapy.

The analysis showed that while no residual tumors were found in low-grade glioma patients, 15.7% of high-grade glioma patients had residual tumors, highlighting the need for careful delineation of radiotherapy target areas based on tumor grade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging evaluation of brain glioma before postoperative radiotherapy. Sui, Z., Zhang, X., Li, H., et al.[2021]

A preparatory study involving three healthy volunteers demonstrated that 7 Tesla MRI can be safely integrated into neurosurgical navigation and radiotherapy planning for glioblastoma, with minimal image quality degradation during processing.

The study confirmed that the spatial accuracy of the 7T MRI images is reliable, with a geometrical distortion of less than 2 mm, making it a promising tool for high-resolution neuroimaging in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility of integrating 7 T anatomical MRI in image-guided radiotherapy of glioblastoma: a preparatory study. Compter, I., Peerlings, J., Eekers, DB., et al.[2018]

In a study of 34 patients treated with stereotactic radiosurgery for brain metastases, it was found that brain metastases and radiation injuries exhibit significantly different signal intensity time courses on MRI after contrast agent application, particularly between 15 and 55 minutes post-contrast.

The research demonstrated that while radiation injuries continued to show increased signal intensity over time, brain metastases showed a decrease, indicating that delayed contrast MRI can enhance diagnostic accuracy in distinguishing between these two conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of Lesions after Stereotactic Radiosurgery for Brain Metastases: Impact of Delayed Contrast Magnetic Resonance Imaging. Wagner, S., Gufler, H., Eichner, G., et al.[2018]

In a study of 61 glioblastoma patients undergoing 6 weeks of chemoradiation therapy, significant changes in tumor size and position were observed, with 40% of patients showing a decrease in tumor volume and notable migration distances greater than 5 mm during treatment.

These findings suggest that MRI-guided radiation therapy could enhance treatment outcomes by allowing for real-time adaptations to tumor dynamics, highlighting the importance of daily imaging in managing glioblastoma effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitating Interfraction Target Dynamics During Concurrent Chemoradiation for Glioblastoma: A Prospective Serial Imaging Study. Stewart, J., Sahgal, A., Lee, Y., et al.[2021]

In a study of 28 patients with high-grade glioma, significant changes in the position and volume of the resection cavity were observed between immediate postoperative MRI and radiation treatment planning MRI, highlighting the importance of using the most current imaging for accurate treatment planning.

These findings suggest that performing an MRI closer to the start of radiation therapy can help optimize target volume delineation, potentially reducing the risk of geographic miss and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Postoperative Changes in Brain Anatomy on Target Volume Delineation for High-Grade Glioma. Dejonckheere, CS., Thelen, A., Simon, B., et al.[2023]

In a study of 34 pediatric patients with brainstem gliomas, MRI was effective in monitoring tumor response to radiation therapy and detecting issues like tumor progression and post-treatment complications, with no cases of radionecrosis found at autopsy.

While MRI correlation with clinical outcomes was not optimal at six weeks post-treatment, it showed strong alignment with clinical evaluations at 4-10 months, suggesting its usefulness for long-term monitoring after therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric brainstem glioma. Post-radiation clinical and MR follow-up. Smith, RR., Zimmerman, RA., Packer, RJ., et al.[2019]

Magnetic resonance imaging (MRI) has become the preferred method for monitoring patients with irradiated brain tumors, as it can detect pathological signals that are not visible on computerized tomography (CT), improving treatment adjustments and diagnostic accuracy in one-third of cases studied.

While MRI does not definitively distinguish between radiation damage and tumor recurrence, certain imaging characteristics can suggest specific diagnoses, and the use of gadolinium contrast enhances the clarity of MRI results, making it the reference standard for evaluating brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of irradiated brain tumours. Value of magnetic resonance imaging. Castel, JC., Caillé, JM.[2019]

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]

In a study involving 16 patients who underwent Gamma Knife radiosurgery, the combination of (18)F-FDG PET/CT and MRI demonstrated a sensitivity of 64.7% and a specificity of 100% in differentiating between adverse radiation effects and tumor recurrence.

The imaging technique was able to identify tumor presence within areas affected by radiation, suggesting it can be a valuable tool in managing post-radiosurgery cases by focusing on metabolic activity rather than just histological findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Although Non-diagnostic Between Necrosis and Recurrence, FDG PET/CT Assists Management of Brain Tumours After Radiosurgery. Torrens, M., Malamitsi, J., Karaiskos, P., et al.[2017]

Citations

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