Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00297024
First received: February 23, 2006
Last updated: January 3, 2014
Last verified: January 2014

February 23, 2006
January 3, 2014
February 2005
May 2013   (final data collection date for primary outcome measure)
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI
Complete list of historical versions of study NCT00297024 on ClinicalTrials.gov Archive Site
  • - 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 ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • - To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • - 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
Not Provided
Not Provided
 
Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)
MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Neoplasms
Procedure: MRI
Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.
Experimental: MRI for brain mets
Intervention: Procedure: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00297024
UHN REB 04-0750-C
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Cynthia Ménard, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP