Clinical trial NCT05868928: Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
Official title: Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Metastases
Radiosurgery
Keywords: Imaging
Habitat
Recurrence
Prediction
Radiation necrosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of tertiary medical center

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.

Detailed 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.

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.

Primary outcomes:
measure: Time to progression
timeFrame: up to 24 months
Secondary outcomes:
measure: Response rate
timeFrame: up to 24 months
measure: Occurence rate of radiation necrosis
timeFrame: 12 months
measure: Imaging risk score for recurrence
timeFrame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
measure: Tumor habitat analysis
timeFrame: Baseline imaging before SRS, and follow up imaging every 3 months after SRS, up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ho Sung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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