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Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

This study is ongoing, but not recruiting participants.
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: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Brain Neoplasms
 Procedure: MRI
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • - 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 ]

Enrollment: 14
Study Start Date: February 2005
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297024

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Cynthia Ménard, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00297024     History of Changes
Other Study ID Numbers: UHN REB 04-0750-C
Study First Received: February 23, 2006
Last Updated: December 18, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013