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

NCT02212964 | Completed

• 1 other identifier: UWO105014
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injury; Radiation Necrosis

Keywords

Radiation Injury; Radiation Necrosis; Ultra-high field MRI; Susceptibility Weighted Imaging; Post-treatment radiographic imaging change

Outcome Measures

Primary Outcomes (1)

• Disease Progression

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

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Functional and Metabolic Mapping: lead
• London Regional Cancer Program, Canada: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

University of Western Ontario

London, Ontario, N6G2J9, Canada

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ravi S Menon, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

• Glenn Bauman, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

CA (1)