Clinical trial · Observational
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
NCT05868928CI-TRIAL-00077112unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Radiosurgery | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arterial spin labeling (ASL) | Diagnostic Test | — | UNRESOLVED |
| Diffusion-weighted MRI | Diagnostic Test | — | UNRESOLVED |
| Dynamic susceptibility contrast-MRI (DSC-MRI) | Diagnostic Test | — | UNRESOLVED |
| Magnetic resonance imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brain metastases patients who received stereotactic radiosurgery
- description
- Patients with brain metastases who received stereotactic radiosurgery
- interventionNames
- 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)
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- up to 24 months
- description
- The time from the date of SRS for brain metastasis until the date of progression.
Secondary outcomes (4)
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDLe 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
- BACKGROUNDChao 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
- BACKGROUNDJhaveri 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
- BACKGROUNDKirkpatrick 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
- BACKGROUNDLin 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.