Back to resultsRadiotherapy - Cerebrovascular Reactivity (RT-CVR Study)
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms
Eligibility Criteria
Inclusion Criteria: Patients with primary gliomas visible on MRI who are planning to receive radiotherapy or Patients with brain metastases>1cm who are planning to receive radiotherapy Karnofsky Performance Status >60 Age 18 years Patients must be willing to visit Toronto Western Hospital for at least one MRI scan prior radiotherapy Exclusion Criteria: Seizures not controlled with medications, or non compliance with prescribed anti-seizure medication Prior radiation therapy to the brain Pregnancy Unwilling or unable to co-operate with breathing maneuvers Respiratory or cardiac limitations to breathing at 20 L/min Medical contra-indications to limited hypercapnia or hypocapnia (known increased intracerebral pressure, metabolic acidosis or alkalosis) Contraindication to MRI (patients weighing>136 kgs-weight limit for the scanner tables; allergy to MR contrast agent; patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI) Other medical conditions deemed by the PI or associates to make the patients ineligible for protocol procedures
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI for brain mets
Arm Description
Outcomes
Primary Outcome Measures
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI
Secondary Outcome Measures
- To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI
- To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements
- To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up
- To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy
Full Information
NCT ID
NCT00297024
First Posted
February 23, 2006
Last Updated
January 3, 2014
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00297024
Brief Title
Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)
Official Title
MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
Brief Summary
Brain tumours often have low oxygen levels, and that makes them more resistant to radiation therapy. If patients breathe the right mixture of oxygen during treatment, radiation may work better. In this study, patients with brain tumour will undergo a special MRI test while they breathe different mixtures of oxygen and carbon dioxide to find out whether oxygen levels improve in the tumor. Patients will also be asked to repeat this MRI test during the second week of radiation therapy, as well as 3 months, 6 months and 1 year after RT. The MRI test after RT will help us understand how the blood vessels in the normal brain are affected by radiation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI for brain mets
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.
Primary Outcome Measure Information:
Title
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI
Time Frame
2 years
Secondary Outcome Measure Information:
Title
- To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI
Time Frame
2 years
Title
- To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements
Time Frame
2 years
Title
- To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up
Time Frame
2 years
Title
- To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with primary gliomas visible on MRI who are planning to receive radiotherapy or
Patients with brain metastases>1cm who are planning to receive radiotherapy
Karnofsky Performance Status >60
Age 18 years
Patients must be willing to visit Toronto Western Hospital for at least one MRI scan prior radiotherapy
Exclusion Criteria:
Seizures not controlled with medications, or non compliance with prescribed anti-seizure medication
Prior radiation therapy to the brain
Pregnancy
Unwilling or unable to co-operate with breathing maneuvers
Respiratory or cardiac limitations to breathing at 20 L/min
Medical contra-indications to limited hypercapnia or hypocapnia (known increased intracerebral pressure, metabolic acidosis or alkalosis)
Contraindication to MRI (patients weighing>136 kgs-weight limit for the scanner tables; allergy to MR contrast agent; patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI)
Other medical conditions deemed by the PI or associates to make the patients ineligible for protocol procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Ménard, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)
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