Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

Completed

• Conditions: Brain Tumor; Glioblastoma Multiforme

• Registration Number: NCT02006563
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-06-08
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Primary Completion: 2016-01
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States