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

37 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).

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 data supports the effectiveness of the treatment MRI after radiosurgery for brain cancer?

Research shows that MRI is very sensitive in tracking changes in brain tumors after radiosurgery, helping doctors distinguish between tumor growth and treatment effects. This means MRI can be a useful tool in monitoring how well the treatment is working. ^{1 2 3 4 5}

Is MRI safe for humans after radiosurgery for brain cancer?

The studies focus on using MRI to monitor brain changes after radiosurgery, but they do not report any specific safety concerns related to MRI itself. MRI is generally considered safe for humans, as it uses magnetic fields and radio waves, not radiation. ^{1 2 3 6 7}

How does MRI after radiosurgery for brain cancer differ from other treatments?

This treatment is unique because it uses MRI after stereotactic radiosurgery (a precise form of radiation therapy) to monitor brain cancer, helping to distinguish between tumor regrowth and radiation-induced changes. This approach enhances diagnostic accuracy and aids in decision-making for further treatment. ^{1 2 8 9 10}

Research Team

Scott Floyd, MD PhD

Principal Investigator

Duke Health

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

Group I: MRI Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

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 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 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 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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transient enlargement of contrast uptake on MRI after linear accelerator (linac) stereotactic radiosurgery for brain metastases. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Characterisation of Lesions after Stereotactic Radiosurgery for Brain Metastases: Impact of Delayed Contrast Magnetic Resonance Imaging. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

T1/T2 matching to differentiate tumor growth from radiation effects after stereotactic radiosurgery. [2010]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Serial MR imaging of intracranial metastases after radiosurgery. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Water Exchange Rate Constant as a Biomarker of Treatment Efficacy in Patients With Brain Metastases Undergoing Stereotactic Radiosurgery. [2018]

6. Greece pubmed.ncbi.nlm.nih.gov

Although Non-diagnostic Between Necrosis and Recurrence, FDG PET/CT Assists Management of Brain Tumours After Radiosurgery. [2017]

7. England 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effects of effective stereotactic radiosurgery for brain metastases on the adjacent brain parenchyma. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery and brain tolerance: an analysis of neurodiagnostic imaging changes after gamma knife radiosurgery for arteriovenous malformations. [2019]

10. United States 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. [2015]