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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Cynthia Ménard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 04-0750-C

NCT ID:

NCT00297024

Start Date:

February 2005

Completion Date:

February 2013

Related Keywords:

  • Brain Neoplasms
  • Brain Neoplasms
  • Neoplasms

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