Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297024
• Other study ID #: UHN REB 04-0750-C
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2006
• Last updated: January 3, 2014
• Start date: February 2005
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- To measure the inter-patient variability of change in tumour oxygenation with carbogen adminstration using MRI		2 years	No
Secondary	- To determine whether modulation of oxygen and carbon dioxide administration can improve tumour oxygenation relative to standard carbogen breathing on MRI		2 years	No
Secondary	- To determine whether changes in tumour oxygenation with carbogen administration are different during the second week of radiotherapy compared to baseline measurements		2 years	No
Secondary	- To determine whether the normal brain cerebrovascular reactivity (CVR) measured with MRI changes through a course of radiotherapy and follow-up		2 years	No
Secondary	- To determine whether CVR differs between radiation exposed and non-exposed normal brain tissue in a given patient after radiotherapy		2 years	No