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TerminatedNot applicableNCT02005614
Official study title

A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGamma Knife Radiosurgery

The study team can explain what participation involves.

Who it may be forMelanoma · Renal Cell Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 1, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Yale University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Yale University
Interventions being studied
Procedure: Gamma Knife Radiosurgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Radiation therapy→Surgery→
Study topics
Brain metastases→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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