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.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms
• Intervention / Treatment: Procedure: MRI

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
- To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI	2 years
- To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements	2 years
- To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up	2 years
- To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy	2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Cynthia Ménard, MD, Princess Margaret Hospital, Canada

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 23, 2006
• First Submitted That Met QC Criteria: February 23, 2006
• First Posted (Estimate): February 27, 2006

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: UHN REB 04-0750-C