MDACC Study Summary 2007-0492 (Archived)

Study Summary
No. 2007-0492:.......Brain......John DeGroot......Neuro Oncology

Study Summary Title



Study Summary Number:	2007-0492

Study Title:	Quantifying Progression of Non-Enhancing Tumor in Patients with Recurrent Glioblastoma Treated with Antiangiogenic agents

Physician

New Patient Referral



Name:	John DeGroot	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7255 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Frequency is defined by the standard of care, which is approximately every 8 weeks.

Treatment Agents:	None	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to learn if magnetic resonance
imaging with magnetic resonance spectroscopy ("MRI/MRS" scanning) can measure
any extra growth in the tumor that does not show up on regular MRI images. This
study procedure will be performed on patients with recurrent glioblastoma who
are either being treated with chemotherapy that blocks blood vessel growth, or
will soon begin this type of chemotherapy.

Study Objectives / Outcomes

The overall goal of this proposed pilot study is to obtain quantitative non-invasive imaging biomarker measures using dynamic susceptibility change MRI (DSC-MRI) perfusion, dynamic contrast enhanced MRI (DCE-MRI), diffusion-weighted MRI and diffusion tensor (DW-MRI/DTI), and proton MR spectroscopy (1H MRS) techniques in patients with invasive non-enhancing tumor treated with antiangiogenic agents and to compare such imaging biomarkers with tissue-based measures from targeted biopsy samples and circulating growth factors circulating myeloid cells and biomarkers of invasion.

The specific aims of this project are:
1. to incorporate DSC and DCE-MRI, DW-MRI, and MRS techniques and analysis tools into the clinical MRI exam to determine longitudinal changes in perfusion, cellularity and metabolism in patients with recurrent glioblastoma tumors undergoing treatment with antiangiogenic chemotherapy

2. to compare quantitative MR measurements from patients with histopathological and immunohistochemical (IHC) findings from surgical specimens.

3. to evaluate changes in circulating levels of growth factors and myeloid cells that coincide with tumor invasion.

Study Status Information



Study Activation / Registration Date:	07/09/2008

IRB Review and Approval Date:	08/10/2007

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol

2) Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab.

3) Patients tumor must be located in an area that is amenable to the proposed imaging sequences.

4) Patients must be age 18 or older.

5) KPS >/= 70.

6) Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial.

7) Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.

Exclusion Criteria:

1) Patients who received previous anti-angiogenic chemotherapy.

2) Patients who are unwilling to come back for regular assessments of response.

3) Patients with claustrophobia or obesity (exceeding the equipment weight limits).

4) Estimated GFR < 35 mL/min

5) Patients with pacemakers or other metallic inserts that are not compatible with 3-T MR scanners.

Links

Registration Number: NCT00777686
Study Information on Clinical Trials Registry (clinicaltrials.gov)