Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme

Glioblastoma Clinical Trial

Official title:

Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme Response to Treatment With Bevacizumab for Progressive Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604590
• Other study ID #: 101652, MUSC
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: April 10, 2015
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. This study will use a new MRI technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

Description:

This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. Bevacizumab is a drug that your doctor believes is the best treatment option available to subjects at this time for this type of tumor. Bevacizumab affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving the tumor of oxygen and food.

Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department that takes pictures of your body using special magnets, rather than X-rays. With a new MRI scan technique the investigators can take very, very detailed images of the vessel and tumor structure. This project will allow us to compare the images of vessel and tumor structure to the effectiveness of Bevacizumab as a treatment option. With this project the investigators will hopefully develop an accurate way to predict whether or not Bevacizumab will be an effective treatment option for patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 80 years of age

• Progressive glioblastoma patients who have been planned to receive bevacizumab

• Karnofsky Performance Status 50 or above (vd. Appendix A)

• Established pathologic diagnosis of glioblastoma

• Prior treatment with radiation and chemotherapy

• Neuroimaging progression of glioblastoma

• Able and willing to provide informed consent (or consent of a guardian)

Exclusion Criteria:

• Contraindication to MRI

• Contraindication to bevacizumab therapy

• Concurrent enrollment in other neuroimaging trials

• Prior therapy with bevacizumab

• Known hypersensitivity to MRI contrast

• Females who are nursing or pregnant

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI to show differences between bevacizumab responses	The MRI parameters will help show the differences between bevacizumab-responsive and bevacizumab non-responsive recurrent glioblastoma	1 month	No
Secondary	Progression Free Survival at 3 months	The progression of the subject's disease will be evaluated at 3 months.	3 months	No