Radiotherapy - Cerebrovascular Reactivity (RT-CVR Study) - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00297024

Purpose

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.

Condition	Intervention	Phase
Brain Neoplasms	Procedure: MRI	Phase II

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	MRI Changes With Administered Oxygen and Carbon Dioxide in Patients With Brain Tumors Receiving Radiotherapy: A Pilot Study

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297024

Contacts

Contact: Cynthia Ménard, MD

416-946-2936

Cynthia.Ménard@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Ménard Cynthia, MD 416-946-2936 Cynthia.Ménard@rmp.uhn.on.ca
Principal Investigator: Cynthia Ménard, MD

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:	Cynthia Ménard, MD	Princess Margaret Hospital, Canada
Principal Investigator:	Cynthia Ménard, MD	Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 04-0750-C
Study First Received:	February 23, 2006
Last Updated:	February 23, 2006
ClinicalTrials.gov Identifier:	NCT00297024
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009