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Completed

NCT Number: NCT00610285

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

Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.

This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.

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Key information

Conditions

Metastatic Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)

Other

Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.

Primary outcomes

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

    Time frame: conclusion of study

Secondary outcomes

  1. Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the accuracy of an image guided non-invasive (Aktina stereotactic localizer) immobilization system on the same 10 patients as in above.

    Time frame: conclusion of study

  2. Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRS

    Time frame: conclusion of the study

  3. Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2008
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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