Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000396820
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
10/04/2012
Date last updated
11/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Assess the Usefulness of a Magnetic Resonance Imaging Technique for Staging of Head and Neck Cancer
Scientific title
PROPELLER-DWI in the Staging of Head and Neck Squamous Cell Carcinoma - A Pilot Study
Secondary ID [1] 280246 0
Nil
Universal Trial Number (UTN)
U1111-1129-6286
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck squamous cell carcinoma 286200 0
Condition category
Condition code
Cancer 286409 286409 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic resonance imaging, diffusion weighted imaging (MRI/DWI). This test will take approximately one hour, including the completion of a safety screening questionnaire. It will be performed only once on each participant.
Intervention code [1] 284590 0
Diagnosis / Prognosis
Comparator / control treatment
Positron emission tomography/computed tomography (PET/CT). This test is part of every participant's standard clinical care. It will take approximately one hour. It will be performed only once on each participant during the trial. The research MRI/DWI test and the PET/CT test will not be performed on the same day, but they will be performed within one week of each other.
Control group
Active

Outcomes
Primary outcome [1] 286856 0
Sensitivity and specificity in the detection of malignant lymph nodes, as compared to PET/CT.
Timepoint [1] 286856 0
At time of diagnosis/cancer staging
Secondary outcome [1] 296811 0
None
Timepoint [1] 296811 0
Not applicable

Eligibility
Key inclusion criteria
Patients with newly diagnosed or recurrent head and neck squamous cell carcinoma who require PET/CT for staging
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not consent to participation; patients who have a contraindication to MRI

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 4231 0
Canada
State/province [1] 4231 0
Nova Scotia

Funding & Sponsors
Funding source category [1] 285008 0
Charities/Societies/Foundations
Name [1] 285008 0
Radiological Society of North America Research & Education Foundation
Country [1] 285008 0
United States of America
Primary sponsor type
Individual
Name
Dr. Matthias Schmidt
Address
Department of Diagnostic Imaging
Halifax Infirmary
Room 3388 - 1796 Summer Street
Halifax, Nova Scotia, B3H 3A7
Country
Canada
Secondary sponsor category [1] 283872 0
None
Name [1] 283872 0
Address [1] 283872 0
Country [1] 283872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287014 0
Capital Health Research Ethics Board
Ethics committee address [1] 287014 0
Centre for Clinical Research
Room 118
5790 University Avenue
Halifax, Nova Scotia, B3H 1V7
Ethics committee country [1] 287014 0
Canada
Date submitted for ethics approval [1] 287014 0
19/03/2012
Approval date [1] 287014 0
Ethics approval number [1] 287014 0
CDHA-RS/2012-330

Summary
Brief summary
Before a patient with head and neck cancer can be treated, it is important to know how far the cancer has spread. For example, it is important to know if the cancer has spread to any of the lymph nodes in the neck. To make this determination currently, doctors examine patients, and they order tests such as MRI (magnetic resonance imaging) and PET/CT (positron emission tomography/computed tomography). Although these tests are good at detecting cancer spread, they are not perfect. Recent research has shown that an MRI technique called DWI (diffusion weighted imaging) can improve the detection of cancer. With DWI, it is possible to measure the apparent diffusion coefficient (ADC) of tissues such as lymph nodes. The ADC is reduced in lymph nodes that have been infiltrated by cancer cells.

We have been using DWI clinically for a long time. However, we have not yet used DWI for staging of head and neck cancer. The major drawback of DWI is that the images generated by this technique can be degraded by motion, such as breathing and swallowing, and by signal disturbance from the airways. This is particularly problematic in the neck. We have available to us a variant of DWI, called PROPELLER-DWI. This technique was designed to overcome image degradation by motion and signal disturbances from air and bone. We have used PROPELLER-DWI clinically to diagnose some patients who had difficulty holding still in the MRI scanner or who had disease at the skull base. To our knowledge, no-one has tried to use PROPELLER-DWI to stage patients with head and neck cancer.

Because of the benefits of DWI demonstrated by others, and because of the theoretical additional benefits of PROPELLER-DWI, we wish to conduct a pilot study to test the feasibility of PROPELLER-DWI for staging of head and neck cancer, comparing it to conventional DWI in this setting. If PROPELLER-DWI shows promise in this pilot project, we will have the justification and the necessary information to plan a larger, prospective study, involving more patients. Ultimately, we hope to improve outcomes for patients with head and neck cancer through more accurate staging.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34002 0
Address 34002 0
Country 34002 0
Phone 34002 0
Fax 34002 0
Email 34002 0
Contact person for public queries
Name 17249 0
Dr. Matthias Schmidt
Address 17249 0
Room 3388 - 1796 Summer Street
Halifax, Nova Scotia, B3H 3A7
Country 17249 0
Canada
Phone 17249 0
1 902 473 5332
Fax 17249 0
Email 17249 0
[email protected]
Contact person for scientific queries
Name 8177 0
Dr. Matthias Schmidt
Address 8177 0
Room 3388 - 1796 Summer Street
Halifax, Nova Scotia, B3H 3A7
Country 8177 0
Canada
Phone 8177 0
1 902 473 5332
Fax 8177 0
Email 8177 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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