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Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

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ClinicalTrials.gov Identifier: NCT02006563
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Radka S. Stoyanova, University of Miami

Brief Summary:
  • 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.

Condition or disease
Brain Tumor Glioblastoma Multiforme

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
Actual Study Start Date : June 8, 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It is estimated that approximately 39% of the patients with primary brain tumors, seen in the Department of Radiation Oncology, Sylvester Cancer Center are women. Further, it is estimated that 58% of patients are White, 6% are African American, 36% are Hispanic and 0% are other based upon standard NIH definitions.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006563


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Radka Stoyanova, PhD University of Miami

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Responsible Party: Radka S. Stoyanova, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02006563     History of Changes
Other Study ID Numbers: 20100809
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radka S. Stoyanova, University of Miami:
Brain Tumor
Glioblastoma multiforme
GBM
Metabolic Tumor Volume
MTV
Clinical Tumor Volume
CTV

Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases