Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

Brain Metastases Clinical Trial

Official title:

Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868928
• Other study ID #: AsanMCHSKim_07
• Status: Recruiting
• Start date: December 7, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: Ho Sung Kim, MD, PhD
• Phone: +82230105682
• Email: radhskim[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

Description:

PRIMARY OBJECTIVE:

I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.

II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.

SECONDARY OBJECTIVE:

I. To predict radiation necrosis using imaging risk score.

OUTLINE:

Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases

2. Patients with lesions eligible for SRS :

• One to ten newly diagnosed brain metastases

• Patients without acute neurological symptom

3. Patients with a Karnofsky performance status score of 70 or higher

4. Patients who underwent brain MRI within 1 month of enrollment

5. Patients with measurable enhancing lesions on MRI.

6. Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard.

7. A longest diameter > 1.5 cm for tumor habitat analysis.

Exclusion criteria:

1. Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.

2. Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.

3. Patients with age < 18 years.

4. Patients without baseline MRI.

5. Patients with nonmeasurable enhancing lesions on MRI : all other lesions, including lesions with longest dimension < 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Radiosurgery
• Recurrence

Intervention

Diagnostic Test:
• Magnetic resonance imaging (MRI)
Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image
• Diffusion-weighted MRI
Diffusion-weighted MRI
• Arterial spin labeling (ASL)
Cerebral blood flow imaging parameter
• Dynamic susceptibility contrast-MRI (DSC-MRI)
Cerebral blood volume and vessel architectural imaging parameters

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

Chao ST, Ahluwalia MS, Barnett GH, Stevens GH, Murphy ES, Stockham AL, Shiue K, Suh JH. Challenges with the diagnosis and treatment of cerebral radiation necrosis. Int J Radiat Oncol Biol Phys. 2013 Nov 1;87(3):449-57. doi: 10.1016/j.ijrobp.2013.05.015. Epub 2013 Jun 19. — View Citation

Jhaveri J, Chowdhary M, Zhang X, Press RH, Switchenko JM, Ferris MJ, Morgan TM, Roper J, Dhabaan A, Elder E, Eaton BR, Olson JJ, Curran WJ, Shu HG, Crocker IR, Patel KR. Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg. 2018 Apr 20;130(3):797-803. doi: 10.3171/2017.9.JNS171735. — View Citation

Kirkpatrick JP, Wang Z, Sampson JH, McSherry F, Herndon JE 2nd, Allen KJ, Duffy E, Hoang JK, Chang Z, Yoo DS, Kelsey CR, Yin FF. Defining the optimal planning target volume in image-guided stereotactic radiosurgery of brain metastases: results of a randomized trial. Int J Radiat Oncol Biol Phys. 2015 Jan 1;91(1):100-8. doi: 10.1016/j.ijrobp.2014.09.004. Epub 2014 Oct 21. — View Citation

Le Rhun E, Guckenberger M, Smits M, Dummer R, Bachelot T, Sahm F, Galldiks N, de Azambuja E, Berghoff AS, Metellus P, Peters S, Hong YK, Winkler F, Schadendorf D, van den Bent M, Seoane J, Stahel R, Minniti G, Wesseling P, Weller M, Preusser M; EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. EANO-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with brain metastasis from solid tumours. Ann Oncol. 2021 Nov;32(11):1332-1347. doi: 10.1016/j.annonc.2021.07.016. Epub 2021 Aug 6. No abstract available. — View Citation

Lee DH, Park JE, Kim N, Park SY, Kim YH, Cho YH, Kim HS. Tumor habitat analysis by magnetic resonance imaging distinguishes tumor progression from radiation necrosis in brain metastases after stereotactic radiosurgery. Eur Radiol. 2022 Jan;32(1):497-507. doi: 10.1007/s00330-021-08204-1. Epub 2021 Aug 6. — View Citation

Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27. — View Citation

Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7. — View Citation

Sneed PK, Mendez J, Vemer-van den Hoek JG, Seymour ZA, Ma L, Molinaro AM, Fogh SE, Nakamura JL, McDermott MW. Adverse radiation effect after stereotactic radiosurgery for brain metastases: incidence, time course, and risk factors. J Neurosurg. 2015 Aug;123(2):373-86. doi: 10.3171/2014.10.JNS141610. Epub 2015 May 15. — View Citation

Stockham AL, Tievsky AL, Koyfman SA, Reddy CA, Suh JH, Vogelbaum MA, Barnett GH, Chao ST. Conventional MRI does not reliably distinguish radiation necrosis from tumor recurrence after stereotactic radiosurgery. J Neurooncol. 2012 Aug;109(1):149-58. doi: 10.1007/s11060-012-0881-9. Epub 2012 May 26. — View Citation

Tsao MN, Rades D, Wirth A, Lo SS, Danielson BL, Gaspar LE, Sperduto PW, Vogelbaum MA, Radawski JD, Wang JZ, Gillin MT, Mohideen N, Hahn CA, Chang EL. Radiotherapeutic and surgical management for newly diagnosed brain metastasis(es): An American Society for Radiation Oncology evidence-based guideline. Pract Radiat Oncol. 2012 Jul-Sep;2(3):210-225. doi: 10.1016/j.prro.2011.12.004. Epub 2012 Jan 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	The time from the date of SRS for brain metastasis until the date of progression.	up to 24 months
Secondary	Response rate	The response is determined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria. Clinical and radiologic assessments per lesion and person are carried out at every MRI follow-up using the MRI before SRS as the baseline.	up to 24 months
Secondary	Occurence rate of radiation necrosis	The rate of occurrence of radiation necrosis per lesion is determined through a combination of imaging findings and clinical evaluation by a multidisciplinary team.	12 months
Secondary	Imaging risk score for recurrence	To calculate the imaging risk score, three parameters are added together, namely the "solid component score," the "less enhancing component score," and the "blood flow score," using contrast-enhanced T1-weighted image(T1WI), T2-weighted image (T2WI), diffusion-weighted imaging (DWI), and ASL.; The solid component risk score is assigned 0, 1, or 2 points, depending on whether the hypointense lesion on T2WI matches the enhancement in CE-T1WI.; The less-enhancing component risk score evaluates the degree of enhancement of the lesion to the dura. It assigns 0, 1, or 2 points depending on whether it is brighter, similar, or less enhanced.; The blood flow risk score assigns 0, 1, or 2 points based on the degree of blood flow of the lesion in ASL.	Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Secondary	Tumor habitat analysis	Automated process of tumor habitat analysis will include followings.; A. Methods: preprocessing includes registration, deep learning segmentation, and normalization of contrast-enhanced T1-weighted (CE-T1) and T2-weighted images. K-means clustering is applied to CE-T1-weighted and T2-weighted images to construct structural MRI habitats and to apparent diffusion coefficient (ADC) and cerebral blood volume (CBV) images to construct physiologic habitats.; B. Structural MRI habitats: enhancing tissue habitat, solid low-enhancing habitat, and nonviable tissue habitat; C. Physiologic MRI habitats: hypervascular cellular habitat, hypovascular cellular habitat, and nonviable tissue habitat..; D. Quantitative measurement of each habitat will be performed.	Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months