Clinical trial NCT00297024: Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)
Official title: MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2006-02-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: - To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI
timeFrame: 2 years
Secondary outcomes:
measure: - To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI
timeFrame: 2 years
measure: - To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements
timeFrame: 2 years
measure: - To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up
timeFrame: 2 years
measure: - To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Cynthia Ménard, MD
role: PRINCIPAL_INVESTIGATOR
References: