Using MRI to predict recurrence risks after brain radiosurgery
Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
This study is testing if special MRI scans can help predict the chances of brain cancer coming back after treatment with targeted radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05868928 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to develop and validate an imaging risk score that predicts the likelihood of recurrence after stereotactic radiosurgery (SRS) in patients with brain metastases. Participants will undergo multi-parametric magnetic resonance imaging (MRI) before and every three months after SRS to gather comprehensive imaging data. The study will utilize both retrospective and prospective validation methods to assess the accuracy of the imaging risk score in predicting radiation necrosis. By improving early diagnosis, this approach may help in tailoring treatment strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates include patients with one to ten newly diagnosed brain metastases who have undergone SRS and have a Karnofsky performance status score of 70 or higher.
Not a fit: Patients with prior brain surgery, SRS, or whole-brain radiation therapy, as well as those with certain types of cancer or under 18 years old, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early diagnosis of radiation necrosis and improve treatment strategies for patients with brain metastases.
How similar studies have performed: While the approach of using multi-parametric MRI for predicting outcomes in brain metastases is promising, it is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Ho Sung Kim, MD, PhD — Asan Medical Center
- Study coordinator: Ho Sung Kim, MD, PhD
- Email: radhskim@gmail.com
- Phone: +82230105682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.