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

NCT05868928 | Recruiting DMC

• 1 other identifier: AsanMCHSKim_07
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Metastases; Radiosurgery

Keywords

Imaging; Habitat; Recurrence; Prediction; Radiation necrosis

Outcome Measures

Primary Outcomes (1)

• Time to progression

  The time from the date of SRS for brain metastasis until the date of progression.

  up to 24 months

Secondary Outcomes (4)

• Response rate

  up to 24 months

• Occurence rate of radiation necrosis

  12 months

• Imaging risk score for recurrence

  Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months

• Tumor habitat analysis

  Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months

Study Arms (1)

Brain metastases patients who received stereotactic radiosurgery

Patients with brain metastases who received stereotactic radiosurgery

Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Diffusion-weighted MRI; Diagnostic Test: Arterial spin labeling (ASL); Diagnostic Test: Dynamic susceptibility contrast-MRI (DSC-MRI)

Interventions

Magnetic resonance imaging (MRI) DIAGNOSTIC_TEST

Pre-and post-contrast enhanced T1-weighted image, T2-weighted image, fluid-attenuated inversion recovery image

Brain metastases patients who received stereotactic radiosurgery

Diffusion-weighted MRI DIAGNOSTIC_TEST

Diffusion-weighted MRI

Brain metastases patients who received stereotactic radiosurgery

Arterial spin labeling (ASL) DIAGNOSTIC_TEST

Cerebral blood flow imaging parameter

Brain metastases patients who received stereotactic radiosurgery

Dynamic susceptibility contrast-MRI (DSC-MRI) DIAGNOSTIC_TEST

Cerebral blood volume and vessel architectural imaging parameters

Brain metastases patients who received stereotactic radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of tertiary medical center

You may qualify if:

• Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases
• Patients with lesions eligible for SRS :
• One to ten newly diagnosed brain metastases
• Patients without acute neurological symptom
• Patients with a Karnofsky performance status score of 70 or higher
• Patients who underwent brain MRI within 1 month of enrollment
• Patients with measurable enhancing lesions on MRI.
• Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard.
• A longest diameter \> 1.5 cm for tumor habitat analysis.

You may not qualify if:

• Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.
• Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.
• Patients with age \< 18 years.
• Patients without baseline MRI.
• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (11)

• 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.

  PMID: 34364998 BACKGROUND

• 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.

  PMID: 23790775 BACKGROUND

• 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. 2019 Mar 1;130(3):797-803. doi: 10.3171/2017.9.JNS171735. Epub 2018 Apr 20.

  PMID: 29676690 BACKGROUND

• 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.

  PMID: 25442342 BACKGROUND

• 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.

  PMID: 26065612 BACKGROUND

• 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.

  PMID: 22638727 BACKGROUND

• 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.

  PMID: 25925626 BACKGROUND

• 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.

  PMID: 34357451 BACKGROUND

• 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.

  PMID: 33028594 BACKGROUND

• 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.

  PMID: 25978710 BACKGROUND

• Roh YH, Park JE, Park SY, Cho YH, Kim YH, Song SW, Yoon S, Kim HS. Assessment of imaging risks for recurrence after stereotactic radiosurgery for brain metastases (IRRaS-BM). BMC Cancer. 2024 Jul 18;24(1):866. doi: 10.1186/s12885-024-12636-5.

  PMID: 39026289 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Recurrence

Interventions

Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging; Perfusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ho Sung Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Sung Kim, MD, PhD

CONTACT

+82230105682; radhskim@gmail.com

Ji Eun Park, MD, PhD

CONTACT

+82230101505; jieunp@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: May 22, 2023
• Study Start: December 7, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

KR (1)