Imaging Study of Glioblastomas Treated With Avastin

• Sponsor: London Health Sciences Centre (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01549392
• Collaborator: University of Western Ontario, Canada (Other), London Regional Cancer Program, Canada (Other)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study aims to assess the effect of Avastin on brain vascularity and blood-brain permeability using dynamic contrast ct scans (DECT) and MRI imaging. Previous publications have documented the method by which DECT can determine alterations in vascular volume and tissue permeability within tumors and normal brain tissue. Functional maps of cerebral blood flow cerebral blood volume and permeability-surface area can be generated from the DECT studies to assess tumor perfusion. MRI spectroscopy analyzes brain chemistry to detect tumour versus edema versus normal brain. Thirty patients will receive MRI spectroscopy and DECT imaging at the time of presumed recurrence and 3 months later. 15 patients who do not receive Avastin and 15 patients who do receive Avastin as standard treatment for recurrence will be studied with DECT and MRI spectroscopy at baseline and then again in 3 months.

Condition or Disease	Intervention/Treatment	Phase
Malignant Gliomas	Device: DECT; Device: MR spectroscopy	N/A

Detailed Description

The clinical determination of the point of tumour progression or response is difficult to determine using standard diagnostic imaging ie CT/MRI especially following previous treatment with surgery, radiation and chemotherapy. Hemorrhage, edema, inflammation and vascular necrosis.

Both MR spectroscopy and DECT have been reported as being able to define areas of recurrent tumour as opposed to treatment-related effects. We wish to investigate the correlation between MR spectroscopy and DECT in assessing tumour progression or response to Avastin in comparison with patients not receiving Avastin.

Health Canada has approved Avastin for clinical use in patients with recurrent glioblastoma who have previously received temozolomide and radiotherapy. We propose to perform a DECT scan at baseline at presumed tumour progression and again 3 months to determine the effects of tumour progression/response on blood brain barrier permeability and vascular volume. The group of 15 patients will be compared to a group of 15 patients who do not receive Avastin at recurrence involving DECT scanning and MR spectroscopy at the time of the radiological progression and 3 months later.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: DECT/MR Spectroscopy +Avastin -15 Glioma Patients with progression will undergo DECT and MRS before Avastin (10 mg/kg iv q2 weeks until progression) and 3 months later	Device: DECT; DECT at tumor progression and 3 months later; Other Names: 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare ; Device: MR spectroscopy; MR spectroscopy at tumor progression and 3 months later; Other Names: MRI scanner: Siemens 3T Tim Trio Sequences: T1W, DTI Analysis software: Brain voyager
Active Comparator: DECT/MR Spectroscopy no Avastin 15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1	Device: DECT; DECT at tumor progression and 3 months later; Other Names: 3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare ; Device: MR spectroscopy; MR spectroscopy at tumor progression and 3 months later; Other Names: MRI scanner: Siemens 3T Tim Trio Sequences: T1W, DTI Analysis software: Brain voyager

Outcome Measures

Primary Outcome Measures

1. 3 Month Response [at 3 months after initial DECT and MR spectroscopy]

   participants who had reduction of tumor size from avastin at 3 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histological diagnosis of glioblastoma with clinical or radiological evidence of progression as indicated by the RANO criteria 19

• Previous radiation and temozolomide chemotherapy

• Patients must be receiving Avastin chemotherapy as second-line treatment if in the Avastin group

• Study-specific consent

Exclusion Criteria:

• Failure to meet inclusion criteria

• Pregnant or lactating patients

• Allergy to iodine or CT contrast precludes DECT component of study

• Claustrophobia precludes MR Spectroscopy component of study

• Internal metal which would preclude an MRI scan

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Regional Cancer Centre	London	Ontario	Canada	N6A4L6

Sponsors and Collaborators

• London Health Sciences Centre
• University of Western Ontario, Canada
• London Regional Cancer Program, Canada

Investigators

• Principal Investigator: Barbara J Fisher, MD, London Regional Cancer Program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barbara Fisher, Dr, London Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT01549392
• Other Study ID Numbers: LRCP02
• First Posted: Mar 9, 2012
• Last Update Posted: Sep 15, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Barbara Fisher, Dr, London Health Sciences Centre: dynamic enhanced ct scan; mri spectroscopy; recurrent gliomas
• Additional relevant MeSH terms: Glioblastoma; Glioma

Study Results

Participant Flow

Arm/Group Title	DECT/MRS in Patients Receiving Avastin	DECT/MRS in Glioma Patients Not Receiving Avastin
Arm/Group Description	3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks	0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
Period Title: Overall Study
STARTED	3	0
COMPLETED	2	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	DECT/MRS in Patients Receiving Avastin	DECT/MRS in Glioma Patients Not Receiving Avastin	Total
Arm/Group Description	-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later	15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later	Total of all reporting groups
Overall Participants	3	0	3
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	50	50
Age (participants) [Number]
<=18 years	0 0%	0 NaN
Between 18 and 65 years	3 100%	3 Infinity
>=65 years	0 0%	0 NaN
Gender (participants) [Number]
Female	2 66.7%	2 Infinity
Male	1 33.3%	1 Infinity
Region of Enrollment (participants) [Number]
Canada	3 100%	3 Infinity

Outcome Measures

1. Primary Outcome

Title	3 Month Response
Description	participants who had reduction of tumor size from avastin at 3 months
Time Frame	at 3 months after initial DECT and MR spectroscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DECT/MRS in Patients Receiving Avastin	DECT/MRS in Glioma Patients Not Receiving Avastin
Arm/Group Description	-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later	15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
Measure Participants	3	0
Number [participants who had tumor reduction]	3 100%

Adverse Events

Arm/Group Title	DECT/MRS in Patients Receiving Avastin		DECT/MRS in Glioma Patients Not Receiving Avastin
Arm/Group Description	-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later		15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1 DECT: DECT at tumor progression and 3 months later MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
All Cause Mortality
	DECT/MRS in Patients Receiving Avastin		DECT/MRS in Glioma Patients Not Receiving Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DECT/MRS in Patients Receiving Avastin		DECT/MRS in Glioma Patients Not Receiving Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	DECT/MRS in Patients Receiving Avastin		DECT/MRS in Glioma Patients Not Receiving Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.