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Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00297024
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : January 6, 2014
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Procedure: MRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study
Study Start Date : February 2005
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: MRI for brain mets Procedure: MRI
Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.

Primary Outcome Measures :
  1. - To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. - 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 ]
  2. - 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 ]
  3. - 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 ]
  4. - To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00297024

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
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Principal Investigator: Cynthia Ménard, MD Princess Margaret Hospital, Canada
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Responsible Party: University Health Network, Toronto Identifier: NCT00297024    
Other Study ID Numbers: UHN REB 04-0750-C
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases