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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Necrosis; Radiation Injury

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G2J9
      • University of Western Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Progression	R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression	6 months

Collaborators and Investigators

• Sponsor: Centre for Functional and Metabolic Mapping
• Collaborators: Lawson Health Research Institute; London Regional Cancer Program, Canada
• Investigators: Principal Investigator: Ravi S Menon, PhD, Western University, Canada; Principal Investigator: Glenn Bauman, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Susceptibility Weighted Imaging; Ultra-high field MRI; Radiation Injury; Radiation Necrosis; Post-treatment radiographic imaging change
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Body Weight; Necrosis; Disease Susceptibility; Radiation Injuries
• Other Study ID Numbers: UWO105014