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

Sponsor

Centre for Functional and Metabolic Mapping (Other)

Overall Status

Completed

CT.gov ID

NCT02212964

Collaborator

London Regional Cancer Program, Canada (Other), Lawson Health Research Institute (Other)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Jul 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Outcome Measures

Primary Outcome Measures

Disease Progression [6 months]
R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Ravi S Menon, PhD, University of Western Ontario, Canada
Principal Investigator: Glenn Bauman, MD, University of Western Ontario, Canada