ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

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]

Sensitivity and specificity in the detection of malignant lymph nodes, as compared to PET/CT.

Timepoint [1]

At time of diagnosis/cancer staging

Secondary outcome [1]

None

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Nova Scotia

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Radiological Society of North America Research & Education Foundation

Address [1]

820 Jorie Boulevard
Oak Brook, IL 60523

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Capital Health Research Ethics Board

Ethics committee address [1]

Centre for Clinical Research
Room 118
5790 University Avenue
Halifax, Nova Scotia, B3H 1V7

Ethics committee country [1]

Canada

Date submitted for ethics approval [1]

19/03/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Matthias Schmidt

Address

Room 3388 - 1796 Summer Street
Halifax, Nova Scotia, B3H 3A7

Country

Canada

Phone

1 902 473 5332

Fax

mhschmid@dal.ca

Contact person for scientific queries

Name

Dr. Matthias Schmidt

Address

Room 3388 - 1796 Summer Street
Halifax, Nova Scotia, B3H 3A7

Country

Canada

Phone

1 902 473 5332

Fax

mhschmid@dal.ca

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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