Clinical trial NCT02006563: Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors
Official title: Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumor
Glioblastoma Multiforme
Keywords: Brain Tumor
Glioblastoma multiforme
GBM
Metabolic Tumor Volume
MTV
Clinical Tumor Volume
CTV
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Radka Stoyanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: