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OpenTrials
Completed

NCT Number: NCT02212964

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Western Ontario

London, Ontario, N6G2J9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Disease Progression

    Time frame: 6 months

    R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression

Sponsors and collaborators

Lead sponsor

Centre for Functional and Metabolic Mapping

Other

Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  • London Regional Cancer Program, Canada

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 11, 2014
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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