Metabolic Tumor Volumes in Radiation Treatment of Primary Brain Tumors

Glioblastoma Multiforme Clinical Trial

Official title:

Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006563
• Other study ID #: 20100809
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: October 20, 2017
• Start date: June 8, 2011
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioblastoma
• Glioblastoma Multiforme

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors	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	2 years