MRI After Radiosurgery for Brain Cancer

Overseen By Eileen Duffy, RN OCN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Poor surgical candidate, SCLC, Lymphoma, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI technique to determine if it can better distinguish between radiation damage and cancer regrowth in the brain. It targets individuals with brain cancer that has spread from other parts of the body and who have received focused radiation therapy known as stereotactic radiosurgery (SRS). The trial seeks participants whose cancer appears to be progressing again in the brain and who might require surgery. Participants must be able to undergo MRIs and be considered suitable candidates for brain surgery by their doctors. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diagnostic techniques for future patients.

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 sequence is safe for patients with brain metastasis?

Research has shown that MRI, or magnetic resonance imaging, is very safe for most people. A brain MRI does not involve radiation, avoiding the risks associated with it. Studies have found that MRI is often used to examine brain tumors and is generally well-tolerated by patients. No serious side effects are known from having an MRI. Therefore, for those considering joining a trial that uses MRI, the risks are low, and the procedure is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using MRI after radiosurgery for brain cancer because it offers a non-invasive way to closely monitor the effects of treatment and detect any changes in the tumor early. Unlike traditional follow-up methods that may rely on symptoms or less detailed imaging, MRI provides detailed images of the brain, allowing doctors to see the tumor's response to radiosurgery in real-time. This could lead to more personalized treatment plans, ensuring patients get the most effective care tailored to their specific needs.

What evidence suggests that this MRI sequence is effective for distinguishing radiation damage from tumor recurrence in brain cancer?

This trial will evaluate the use of MRI after stereotactic radiosurgery (SRS) for brain tumors. Studies have shown that MRI scans help doctors distinguish between radiation damage and new tumor growth. Research indicates that MRI scans after SRS often reveal a decrease in tumor size, aiding doctors in assessing treatment effectiveness. Multiparametric MRI, which employs various imaging methods, enhances the ability to detect changes in the brain post-treatment, assisting doctors in determining whether a tumor is recurring or if it's merely radiation effects. In about 20% to 30% of cases, initial MRI scans after treatment provide crucial information for subsequent medical decisions. These findings suggest that MRI after SRS serves as a valuable tool in managing brain cancer by improving diagnosis and treatment planning. ^{6 7 8 9 10}

Who Is on the Research Team?

Scott Floyd, MD PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with brain metastasis from solid tumors, excluding small cell lung cancer and lymphoma, who've had stereotactic radiosurgery (SRS). They must be candidates for brain surgery, able to undergo MRI with contrast, and have signed an informed consent.

Inclusion Criteria

Patients must sign study-specific informed consent prior to study entry

My cancer has grown at the site previously treated with radiation.

I have been diagnosed with a metastatic cancer that is not small cell lung cancer or lymphoma.

Exclusion Criteria

I cannot have an MRI with contrast due to a medical condition or allergy.

My doctors have decided surgery is too risky for me.

My cancer is either small cell lung cancer or lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo stereotactic radiosurgery (SRS) for brain metastases

Not specified

MRI Evaluation

Participants receive additional MRI sequences to distinguish radiation damage from tumor recurrence

Baseline

Follow-up

Participants are monitored for safety and effectiveness after MRI evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview

The study is testing if adding another sequence to the MRI scan can better differentiate between tumor regrowth and radiation damage in patients who've undergone SRS for brain metastases.

How Is the Trial Designed?

Group I: MRI Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Linac-based stereotactic radiosurgery is a safe and effective treatment for brain metastases, achieving a 91% local tumor control rate at one and two years, with a median survival of 9 months for patients.

MRI follow-up showed that 81% of treated metastases had stable or reduced contrast-enhancing volumes, indicating positive treatment response, while transient enlargement of these volumes occurred in 12% of cases, which does not necessarily indicate treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient enlargement of contrast uptake on MRI after linear accelerator (linac) stereotactic radiosurgery for brain metastases. Huber, PE., Hawighorst, H., Fuss, M., et al.[2019]

In a study of 68 patients who underwent surgery after stereotactic radiosurgery (SRS) for brain metastases, a T1/T2 mismatch on MRI was found to be a reliable indicator of radiation effects (RE) versus tumor progression, with a sensitivity of 83.3% and specificity of 91.1%.

The timing of surgical resection after SRS also played a crucial role; a shorter interval from SRS to surgery was linked to a higher rate of tumor recurrence, suggesting that careful monitoring and imaging can help determine the need for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T1/T2 matching to differentiate tumor growth from radiation effects after stereotactic radiosurgery. Kano, H., Kondziolka, D., Lobato-Polo, J., et al.[2010]

In a study of 25 patients with 35 intracranial metastases treated with high-dose radiosurgery, 88% showed stable disease, partial, or complete remission, indicating that radiosurgery is an effective treatment for brain metastases.

Magnetic resonance imaging (MRI) was effective in monitoring tumor response and adjacent brain tissue changes, with loss of contrast enhancement being a positive prognostic indicator for treatment success. Most radiation-induced changes in normal brain tissue were temporary and resolved over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial MR imaging of intracranial metastases after radiosurgery. Hawighorst, H., Essig, M., Debus, J., et al.[2019]

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]

The study analyzed MRI features in 32 patients who underwent surgery after radiosurgery for metastatic brain tumors, finding that a novel measure called the lesion quotient can effectively distinguish between radiation necrosis and tumor regrowth, with a quotient of 0.6 or greater indicating recurrent tumor.

While other MRI characteristics showed predictive value for differentiating conditions, they lacked either sensitivity or specificity, making the lesion quotient a more reliable indicator for identifying pure radiation necrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can standard magnetic resonance imaging reliably distinguish recurrent tumor from radiation necrosis after radiosurgery for brain metastases? A radiographic-pathological study. Dequesada, IM., Quisling, RG., Yachnis, A., et al.[2015]

In a study of 31 patients treated with stereotactic radiosurgery for brain metastases, time-dependent MRI changes were effective in distinguishing between radiation-induced injuries and malignancies, with significant differences observed at various time points (2min, 15min, and 55min) after contrast administration.

All radiation-induced injuries displayed a distinct black interior on subtraction images at 15min compared to malignant lesions, which showed white components, indicating that sequential MRI analysis can be a reliable diagnostic tool post-SRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation injury versus malignancy after stereotactic radiosurgery for brain metastases: impact of time-dependent changes in lesion morphology on MRI. Wagner, S., Lanfermann, H., Eichner, G., et al.[2018]

Multiparametric MRI techniques can effectively detect radiation-induced changes in brain tissue adjacent to areas treated with stereotactic radiosurgery (SRS) for brain metastases, even when conventional MRI shows no abnormalities.

In a study of 16 patients with a median follow-up of 39 months, significant changes in metabolic markers were observed, such as low N-acetyl-aspartate and high choline levels near the treatment site, indicating potential for monitoring neuroprotective treatments post-irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of effective stereotactic radiosurgery for brain metastases on the adjacent brain parenchyma. Wagner, S., Lanfermann, H., Wohlgemuth, WA., et al.[2021]

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]

In a study of 19 patients undergoing stereotactic radiosurgery (SRS) for metastatic brain tumors, early changes in the intra-extracellular water exchange rate constant (kIE) measured by MRI were able to differentiate between tumors that responded partially and those that remained stable or progressed.

The study found a strong correlation between early changes in kIE one week after treatment and the extent of tumor shrinkage observed one month later, suggesting that kIE could be a predictive biomarker for treatment response in patients undergoing SRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Water Exchange Rate Constant as a Biomarker of Treatment Efficacy in Patients With Brain Metastases Undergoing Stereotactic Radiosurgery. Mehrabian, H., Desmond, KL., Chavez, S., et al.[2018]

In a study of 72 patients who underwent stereotactic radiosurgery for intracranial arteriovenous malformations, 31% developed post-treatment imaging changes, which were linked to headaches or neurological deficits in 45% of cases.

The majority of imaging changes resolved within 14 months, with treatment volume being the only significant factor associated with the development of these changes, highlighting the importance of careful treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgery and brain tolerance: an analysis of neurodiagnostic imaging changes after gamma knife radiosurgery for arteriovenous malformations. Flickinger, JC., Lunsford, LD., Kondziolka, D., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12080185/

Temporal evolution of MRI findings and survival outcomes in ...

Post-SRS follow-up magnetic resonance imaging (MRI) evaluations typically demonstrate a reduction in the size of metastatic lesions; however, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4086651/

differentiating pseudoprogression from tumor progression ...

Can standard magnetic resonance imaging reliably distinguish recurrent tumor from radiation necrosis after radiosurgery for brain metastases? A radiographic ...

3.

nature.com

nature.com/articles/s41416-020-0853-3

Effects of effective stereotactic radiosurgery for brain ...

Multiparametric MRI can depict radiobiological effects and their time course at a distance from the effectively treated site after SRS for brain ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405631625000594

Magnetic resonance imaging in glioblastoma radiotherapy

The purpose of the study was to examine the safety of adaptive radiotherapy in glioblastoma, using a margin-reduction approach based on an interim magnetic ...

5.

ascopubs.org

ascopubs.org/doi/10.14694/EdBook_AM.2012.32.119

Current Concepts in Brain Tumor Imaging

Most neuro-oncologists obtain an initial posttreatment MRI scan 4 weeks following the radiation therapy phase. In approximately 20% to 30% of cases, this MRI ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9953338/

Magnetic Resonance Imaging of Primary Adult Brain Tumors

This article aimed to provide an overview of neuroimaging in the assessment of adult primary brain tumors.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0361923025001418

Multi-class brain malignant tumor diagnosis in magnetic ...

Moreover, we construct and utilize a novel multi-center two-dimensional tumor imaging dataset, which includes MRI scans from Sir Run Run Shaw ...

8.

mdpi.com

mdpi.com/2504-2289/8/9/123

Brain Tumor Detection Using Magnetic Resonance ...

The best model achieved an accuracy of 97.5%, sensitivity of 99.2%, and binary accuracy of 98.2%, surpassing previous studies. These results underscore the ...

9.

mayoclinic.org

mayoclinic.org/tests-procedures/brain-mri/about/pac-20582237

Brain MRI (brain magnetic resonance imaging)

A brain MRI doesn't use radiation and is considered very safe for most people. You may need a brain MRI for many different reasons. A brain MRI ...

10.

nature.com

nature.com/articles/s41598-024-84386-0

Deep learning-integrated MRI brain tumor analysis

This research or medical imaging study that focuses on the analysis of brain tumor data obtained from MRI (Magnetic Resonance Imaging) scans.