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A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Brain Cancer

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Trial Information

A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases


Inclusion Criteria:



- Histologically confirmed malignancy with the presence of intraparenchymal brain
metastases.

- A diagnostic contrast enhanced MRI demonstrating the presence of brain metastases
performed within two weeks prior to registration.

- Age ≥ 18 years.

- Must be scheduled or planning to be scheduled for SRS treatment.

- Karnofsky performance status ≥60.

- Patient must sign a study-specific informed consent form. If the patient's mental
status precludes his/her giving informed consent, written informed consent may be
given by the patient's legal representative.

Exclusion Criteria:

- Unable to provide informed consent

- Major medical illness including poor cardiac or pulmonary status which would result
in inability of the patient to lie down for the procedure.

- Inability to obtain histologic proof of malignancy.

- Younger than 18 years of age.

- Serum creatinine > 1.3 mg/dl.

- Karnofsky performance status of ≤50.

- Allergy to either CT or MR contrast dyes.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Yoshiya Yamada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-110

NCT ID:

NCT00610285

Start Date:

October 2005

Completion Date:

July 2010

Related Keywords:

  • Metastatic Brain Cancer
  • Brain Neoplasms
  • Neoplasm Metastasis

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021