Clinical trial NCT02212964: Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*
Official title: Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Injury
Radiation Necrosis
Keywords: Radiation Injury
Radiation Necrosis
Ultra-high field MRI
Susceptibility Weighted Imaging
Post-treatment radiographic imaging change
Lead sponsor: Centre for Functional and Metabolic Mapping
Sponsor class: OTHER
Collaborators: name: London Regional Cancer Program, Canada
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2014-08-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Disease Progression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Ravi S Menon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Glenn Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References: