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Completed

NCT Number: NCT02006563

Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

* Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors. * If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV. * Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

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Key information

About this study

Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.

  • If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
  • Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have histologically confirmed primary brain tumor.
  • Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
  • Patients must be 18 years or older.
  • Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
  • Patients who do not suffer from claustrophobia (fear of enclosed spaces)
  • Karnofsky performance status ≥ 60.
  • Patients whose size would allow them to fit into the bore of the MRI instrument.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Patients younger than 18 years.
  • Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
  • Karnofsky performance status < 60.
  • Patients too large (> 300 lbs.) to fit into the bore of the MRI instrument.
  • Inability to understand the informed consent document.

Treatment and study plan

Primary outcomes

  1. Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors

    Time frame: 2 years

    To evaluate the extent to which tumor volumes, determined by spectroscopic imaging (MTV) differ from the traditionally prescribed clinical treatment volumes (CTV) for radiation therapy

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Dec 10, 2013
Registry last updated
Oct 24, 2017

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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