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

Radiation Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212964
• Other study ID #: UWO105014
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: March 30, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Centre for Functional and Metabolic Mapping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease Susceptibility
• Necrosis
• Radiation Injuries
• Radiation Injury
• Radiation Necrosis

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Functional and Metabolic Mapping	Lawson Health Research Institute, London Regional Cancer Program, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression	6 months	No