This trial is active, not recruiting.

Conditions brain tumor, glioblastoma multiforme
Sponsor University of Miami
Start date January 2011
End date January 2016
Trial size 20 participants
Trial identifier NCT02006563, 20100809


- 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
Principal investigator Radka Stoyanova, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Miami.