Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study)

NCT00297024 | Completed Phase 2

• 1 other identifier: UHN REB 04-0750-C
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (4)

• - 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

Study Arms (1)

MRI for brain mets

EXPERIMENTAL

Procedure: MRI

Interventions

MRI PROCEDURE

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

MRI for brain mets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Cynthia Ménard, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 27, 2006
• Study Start: February 1, 2005
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

CA (1)