A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection
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.
Checked against the public recordLast updated Jul 1, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Yale University
- Interventions being studied
- Procedure: Gamma Knife Radiosurgery
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale UniversityNew Haven, Connecticut
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2019. Always confirm current availability with the study team.