Radiation InjuryNCT02212964
Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*
An observational study of Radiation Injury and Radiation Necrosis, run by Centre for Functional and Metabolic Mapping at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Injury, Radiation Necrosis
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Radiation Injury, Radiation Necrosis
- Keywords
- Radiation Injury, Radiation Necrosis, Ultra-high field MRI, Susceptibility Weighted Imaging, Post-treatment radiographic imaging change
- Medical subject headings
- Radiation Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression
R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Functional and Metabolic Mapping
- Sponsor type
- University, hospital or other
- Collaborators
- London Regional Cancer Program, Canada, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
- Investigators
- Ravi S Menon, PhD, Principal investigator, Western University, CanadaGlenn Bauman, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212964
- Sponsor's protocol ID
- UWO105014
- Status last verified
- Mar 2016
- First submitted
- 7 Aug 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Pseudoprogression and True Progression Through High Field Susceptibility Weighted Imaging and R2*
- ClinicalTrials.gov ID
- NCT02212964
- Acronym / sponsor ID
- UWO105014
- Conditions
- Radiation Injury, Radiation Necrosis
- Keywords
- Radiation Injury, Radiation Necrosis, Ultra-high field MRI, Susceptibility Weighted Imaging, Post-treatment radiographic imaging change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre for Functional and Metabolic MappingUniversity, hospital or other
- Collaborators
- London Regional Cancer Program, Canada, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Progression
Time frame: 6 months
R2* and susceptibility-weighted imaging venography to determine retrospectively if pseudoprogression can be distinguished from true progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi S Menon, PhD principal investigator
Western University, Canada
Glenn Bauman, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injury and Radiation Necrosis, run by Centre for Functional and Metabolic Mapping at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.