NCT05868928 Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
| NCT ID | NCT05868928 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Brain Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2023-12-07 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Ho Sung Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT05868928 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05868928 currently recruiting?
Yes, NCT05868928 is actively recruiting participants. Contact the research team at radhskim@gmail.com for enrollment information.
Where is the NCT05868928 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05868928 clinical trial?
NCT05868928 is sponsored by Asan Medical Center. The principal investigator is Ho Sung Kim, MD, PhD at Asan Medical Center. The trial plans to enroll 132 participants.