A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection
Stopped early · Not applicable
Conditions studied: Melanoma, Renal Cell Carcinoma, Sarcoma, Breast Cancer, Lung Cancer, Colorectal Cancer, Gastrointestinal Cancers, Brain Metastases
In brief
The purpose of this study is to collect prospective data for use as a comparator for future subsequent studies attempting to increase the efficacy or reduce the toxicity of gamma knife radiosurgery.
Key facts
- Study ID
- NCT02005614
- Run by
- Yale University
- People needed
- 39
- Starts
- 2013-11-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2019-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have histologically or cytologically confirmed malignancy (not leukemia or lymphoma). There must be metastatic brain disease apparent on magnetic resonance imaging which offers a medical indication for brain radiation. - Age > 18
- Karnofsky Performance Status > 70
- MRI performed within 4 weeks of trial enrollment
- Medical oncologist or consenting physician verifies that chemotherapy options exist after treatment with intracranial therapy, and that chemotherapy is planned to initiate after completion of radiation. Or, survival as estimated by the medical oncologist or enrolling physician is > 3 months.
You may not qualify if…
- Extremely radiosensitive tumor (lymphoma, leukemia)
- Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
- Evidence of leptomeningeal dissemination
- Resection of brain metastases, otherwise untreated with radiation for those brain lesions (presenting for postoperative consolidative radiotherapy)
- Presence of a medical device (pacemaker, stent) or allergy that precludes contrast enhanced MRI
- Patient is unable to tolerate placement of a stereotactic headframe
- Pregnancy
Where it is running
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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