Brain Metastases
Conditions
Brief summary
This study is designed to evaluate whether advanced magnetic resonance imaging (MRI) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion MRI may be used to predict treatment response of brain metastasis after radiosurgery.
Interventions
DEVICEdynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have newly diagnosed brain metastases visible on brain MRI. A biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic. * At least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for DSC-PMR. * Patient must be clinically eligible for and elect to be treated with GK alone without WBRT. * Patient must be ≥ 18 years of age. * Patient must have Karnofsky Performance Status (KPS) of at least 60 * Patient may be part of other clinical trials (as long as no other local treatments beyond GK such as WBRT or other local therapy are indicated to the brain) or imaging studies. * Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
Exclusion criteria
* Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis). * Patient must not be pregnant or breastfeeding. * Patient must not have an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2. * Patient must not have melanoma. * Patient must not have hemorrhagic lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to local progression of each treated and evaluable brain metastasis | At time of radiosurgery and after radiosurgery (approximately 1 week) | Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation necrosis | Up to 1 year | Radiation necrosis will be defined by pathology, when available. When no pathology is available, clinical diagnosis based on clinical course and management will be used. |
| Complete response | Up to 1 year | Complete response = no residue enhancing lesion on MRI |
| Elsewhere brain failure | Up to 1 year | Elsewhere brain failure = appearance of brain metastases outside of the prior radiosurgery region which can be diagnosed radiographically and does not required require pathological confirmation. |
| Clinical deterioration | Up to 1 year | Clinical deterioration will be assessed based on the Karnofsky Performance scale (KPS). * 100=Normal no complaints; no evidence of disease. * 90=Able to carry on normal activity; minor signs or symptoms of disease. * 80=Normal activity with effort; some signs or symptoms of disease. * 70=Cares for self; unable to carry on normal activity or to do active work. * 60=Requires occasional assistance, but is able to care for most of his personal needs. * 50=Requires considerable assistance and frequent medical care. * 40=Disabled; requires special care and assistance. * 30=Severely disabled; hospital admission is indicated although death not imminent. * 20=Very sick; hospital admission necessary; active supportive treatment necessary. * 10=Moribund; fatal processes progressing rapidly. * 0=Dead |
Countries
United States
Outcome results
None listed