Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*

NCT ID: NCT02212964

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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Using a multi-echo gradient echo sequence to calculate R2\* and quantitative susceptibility maps and well as susceptibility-weighted imaging post processing the investigators hypothesize that the investigators would be able to distinguish between pseudoprogression and true progression with the use of an easily implementable sequence on clinical MRI scanners.

Detailed Description

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Post-treatment radiographic imaging change (PTRIC) is seen in approximately 50% of patients who are treated for brain neoplasms using chemotherapy and radiotherapy. PTRIC can be attributed to true disease progression or a form of benign radiographic enhancement, known in literature as pseudoprogression. Of these patients, 50% of them have benign radiographic enhancement that is usually spontaneously resolved and required no intervention. The other 50% require immediate medical intervention, or more aggressive treatment for true progression. Currently standard medical practise is to administer a prophylactic treatment of chemotherapy to all patients with PTRIC with a follow up scan 3-6 months after initial PTRIC diagnosis, leading to up to 50% of patients receiving an unneeded dose of chemotherapy. The investigators hope to take advantage of the differentiation in tissue types and vascularization between true progression tumour and pseudoprogression to be able to identify patients who would not need to be administered a prophylactic dose of chemotherapy.

Conditions

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Radiation Injury Radiation Necrosis

Keywords

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Radiation Injury Radiation Necrosis Ultra-high field MRI Susceptibility Weighted Imaging Post-treatment radiographic imaging change

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

1. The subject must consent to participate.
2. The subject must be above the age of 18.
3. Patients must be classified as possible pseudoprogression or true progression
4. Patients scoring \>= 70 on the karnofsky performance status.

Exclusion Criteria

1. Any subject with contraindication to an MRI procedure as listed in the Magnetic Resonance Environment Screening Questionnaire.
2. Any subject who may be unable to tolerate the MRI environment due to physical size and/or known tendency to claustrophobia.
3. Any subject who does not expect to be available to attend the for the required study MRI scans
4. Patients scoring \< 70 on the karnofsky performance status.
5. Attending radiation oncologist or neurologist determines patient is no longer able to consent for themselves.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Regional Cancer Program, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role collaborator

Centre for Functional and Metabolic Mapping

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ravi S Menon, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Glenn Bauman, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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University of Western Ontario

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UWO105014

Identifier Type: -

Identifier Source: org_study_id