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Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin


N/A
18 Years
90 Years
Open (Enrolling)
Both
Malignant Gliomas

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Trial Information

Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determination of Tumor Progression using DECT and MR spectroscopy scans

Outcome Description:

Dynamic Enhanced Ct imaging (DECT) is a method developed for measurement of blood-brain barrier permeability and vascular volume which can then be graphically represented by functional images. MR spectroscopy is a technique that is able to characterize biochemical, metabolic and pathologic changes of brain tissue to provide information concerning the spatial extent of cellular metabolites in the brain.

Outcome Time Frame:

after second set of DECT and MRI spectroscopy scans (average of 3 months)

Safety Issue:

No

Principal Investigator

Barbara J Fisher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program

Authority:

Canada: Ethics Review Committee

Study ID:

LRCP02

NCT ID:

NCT01549392

Start Date:

February 2012

Completion Date:

March 2015

Related Keywords:

  • Malignant Gliomas
  • dynamic enhanced ct scan
  • mri spectroscopy
  • recurrent gliomas
  • Glioblastoma
  • Glioma

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