Multi-Parametric Brain Cancer MRI
Primary Purpose
Brain Tumors
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3D MRI Scans
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring Primary Brain Cancer
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age.
- Competent to sign informed consent.
- Diagnosed with primary tumor of the brain.
- Undergoing IGRT.
- Willing to participate in initial and follow up scan(s).
- Can lie supine in the MRI scanner for a period of about 45 minutes.
- Has signed informed consent.
Exclusion Criteria:
- Pregnancy.
- Contraindications to MRI (e.g., pacemakers, magnetic implants, metal in eye, claustrophobia).
- Has metallic implants in regions of interest (dental braces are okay).
Sites / Locations
- Cross Cancer Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Additional 3D MRI scans
Arm Description
Participating patients will receive additional 3D MRI scans during pre and post RT planning for their primary brain tumors.
Outcomes
Primary Outcome Measures
Comparisons of radiation treatment plans by means of tumor control probabilities calculated from dose-volume histograms
Secondary Outcome Measures
Full Information
NCT ID
NCT02649699
First Posted
December 31, 2015
Last Updated
January 4, 2017
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02649699
Brief Title
Multi-Parametric Brain Cancer MRI
Official Title
Quantitative and Multi-Parametric 3D Magnetic Resonance Imaging of Primary Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition and processing techniques on primary brain tumor patients. The objectives are to improve image-guided radiation therapy (IGRT) planning (first part of the study) and treatment monitoring (second part).
Detailed Description
In traditional IGRT the radiation treatment is planned and simulated on computers using x-ray computed tomography (CT) images alone or a combination of CT and MRI. The CT mostly provides information about attenuation of radiation beams needed for the dose simulations because most tumours are more readily identified and contoured with MRI. However, fusion of CT and MR images is prone to error and is a time-consuming process that cannot be automated reliably. Previous research (Stanescu et al.) has shown that the attenuation information can be obtained from MRI which, unlike CT, does not use ionizing radiation to create images. Eliminating the CT scan is therefore possible and beneficial to both the patient, who avoids an additional dose of diagnostic x rays, and to the health care system which saves resources that can be used elsewhere.
Our new MRI acquisition and processing techniques (performed at 3 tesla i.e. 3T) enable:
the extraction of 4 different quantitative parameters (hence "multi-parametric MRI", quantitative MRI or relaxometry) that are normally not accessible in traditional MRI, and
the automatic classification of tissues (e.g. bone, air, adipose, soft tissue, etc.) which is needed for dose computation in IGRT planning
In the first part of the study (dosimetry) these MRI methods will be used to generate a pseudo-CT to replace the traditional CT data. The hypothesis is that dosimetry can be accurately calculated for primary brain cancer patients using the pseudo-CT, thus allowing radiation treatment planning using MRI only. The IGRT treatments planned using qMRI will be compared to those planned conventionally.
The second part of the study (treatment monitoring) aims to evaluate the ability of qMRI techniques to provide clinical information such as distinguishing between progression and pseudo-progression, assessing treatment effectiveness or prognosis. The hypothesis is that qMRI can provide increased sensitivity to biological changes in tumors associated with disease progression over conventional (T1- or T2-weighted) MRI. The reasoning is that by providing quantitative, rather than weighted, images, direct numerical comparisons can be made between images acquired at different time points or at different centres. With traditional MRI, only limited, qualitative comparisons of tumor morphology or relative intensity within the same image can be made. Therefore, 3 or more follow-up MRI scans will also be acquired 3, 6 and 12 months after treatment and at recurrence, transformation, or pseudoprogression to monitor the effectiveness of the treatment.
These techniques will be tested on primary brain cancer patients undergoing IGRT, and the following data will be required:
the patient's IGRT treatment plan, as well as the planning CT and MRI datasets, and
additional scanning sessions approximately 45 minutes in duration to acquire MRIs of the patient with the new techniques at 3T. One of the sessions is prior to the beginning of the course of radiation therapy (first part of the study) and the remaining are after the completion of their radiation treatment (second part of the study).
Traditional treatment and follow-up care are unchanged.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
Primary Brain Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Additional 3D MRI scans
Arm Type
Other
Arm Description
Participating patients will receive additional 3D MRI scans during pre and post RT planning for their primary brain tumors.
Intervention Type
Other
Intervention Name(s)
3D MRI Scans
Intervention Description
Patients will receive additional MRI scans before commencing their radiation treatment, at 3-4 months, 6 months and 12 months post RT as well as at recurrence or suspected recurrence.
Primary Outcome Measure Information:
Title
Comparisons of radiation treatment plans by means of tumor control probabilities calculated from dose-volume histograms
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age.
Competent to sign informed consent.
Diagnosed with primary tumor of the brain.
Undergoing IGRT.
Willing to participate in initial and follow up scan(s).
Can lie supine in the MRI scanner for a period of about 45 minutes.
Has signed informed consent.
Exclusion Criteria:
Pregnancy.
Contraindications to MRI (e.g., pacemakers, magnetic implants, metal in eye, claustrophobia).
Has metallic implants in regions of interest (dental braces are okay).
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-Parametric Brain Cancer MRI
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