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

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ClinicalTrials.gov Identifier: NCT02212964
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : March 31, 2016
Sponsor:
Collaborators:
London Regional Cancer Program, Canada
Lawson Health Research Institute
Information provided by (Responsible Party):
Centre for Functional and Metabolic Mapping

Brief Summary:
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.

Condition or disease
Radiation Injury Radiation Necrosis

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Disease Progression [ Time Frame: 6 months ]
    R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have had treatment for brain neoplasms treated with radiation and/or chemotherapy who presents with post-treatment imaging changes on the MRI following treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212964


Locations
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Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6G2J9
Sponsors and Collaborators
Centre for Functional and Metabolic Mapping
London Regional Cancer Program, Canada
Lawson Health Research Institute
Investigators
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Principal Investigator: Ravi S Menon, PhD University of Western Ontario, Canada
Principal Investigator: Glenn Bauman, MD University of Western Ontario, Canada

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Responsible Party: Centre for Functional and Metabolic Mapping
ClinicalTrials.gov Identifier: NCT02212964    
Other Study ID Numbers: UWO105014
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by Centre for Functional and Metabolic Mapping:
Radiation Injury
Radiation Necrosis
Ultra-high field MRI
Susceptibility Weighted Imaging
Post-treatment radiographic imaging change
Additional relevant MeSH terms:
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Necrosis
Disease Susceptibility
Body Weight
Radiation Injuries
Disease Attributes
Pathologic Processes
Signs and Symptoms
Wounds and Injuries