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Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00297024
Enrollment
14
Registered
2006-02-27
Start date
2005-02-28
Completion date
2013-05-31
Last updated
2014-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

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.

Interventions

PROCEDUREMRI

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

Sponsors

Princess Margaret Hospital, Canada
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI2 years

Secondary

MeasureTime frame
- To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI2 years
- To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements2 years
- To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up2 years
- To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026