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Completed

NCT Number: NCT00297024

Radiotherapy - Cerebrovascular Reactivity (RT-CVR 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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

Patients will be scanned while breathing in varying amounts of oxygen and carbon dioxide in varying amounts through a breathing device.

Primary outcomes

  1. - To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Feb 27, 2006
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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