A Phase 1 interventional study of dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging in Brain Metastases, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Diagnostic
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 23 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Exclusion Criteria:
DSC-PMR (dynamic susceptibility-weighted contrast- enhanced perfusion magnetic resonance imaging) at baseline (screening or time of radiosurgery) and after radiosurgery
Device: dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging
Also known as: DSC-PMR
Time to local progression of each treated and evaluable brain metastasis
Tumor perfusion on DSC-PMR will be used as predictor for time to local tumor progression.
Time frame: At time of radiosurgery and after radiosurgery (approximately 1 week)
Radiation necrosis
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.
Time frame: Up to 1 year
Complete response
Complete response = no residue enhancing lesion on MRI
Time frame: Up to 1 year
Elsewhere brain failure
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.
Time frame: Up to 1 year
Clinical deterioration
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
Time frame: Up to 1 year
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine