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Trial registered on ANZCTR


Trial ID
ACTRN12617000597392
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
27/04/2017
Date last updated
27/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
PET/CT (Positron Emission Tomography/Computed Tomography) and PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) for radiation treatment planning in patients with head and neck cancer undergoing definitive radiation or chemoradiation treatment
Scientific title
PET/CT and PET/MRI for radiation treatment planning in patients with head and
neck cancer undergoing definitive radiation or chemoradiation treatment
Secondary ID [1] 291670 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 302828 0
Condition category
Condition code
Cancer 302322 302322 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty patients will undergo an additional imaging session at the Herston Imaging Research Facility (HIRF) on a different day to the standard planning CT scan.
During the additional imaging session which should occur within 7 days of the standard planning CT scan, all twenty patients will undergo a 18-FDG PET/CT (using the Siemens Biograph mCT Flow) and 18-FDG PET/MRI (using the Siemens mMR Biograph PET/MRI ) under the same physical position and set-up as their standard of care radiotherapy CT simulation.
The twenty patients will be split into two cohorts. The ten patients in cohort 1 will have a 18-FDG PET/MRI followed by PET/CT. The ten patients in cohort 2 will have a 18-FDG PET/CT followed by PET/MRI. The PET/MRI data from the pre-PET/CT cohort 1 will be used to investigate the value of dynamic imaging of the kinetics of FDG uptake.

You will be asked to fast for up to 6 hours prior to the scan session. A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called FDG.

If you are having the PET/MRI first then the scan will start immediately during the period known as the uptake time. You will be positioned in a way that closely matches your radiation therapy treatment position. The scan involves lying flat with knees and neck supported. The scan time for the FDG PET/MRI is approximately 1 hour. After the examination is completed, you will be asked to empty your bladder and move to the PET/CT scanner where the scan will commence. The exam will take approximately 30 minutes. After the examination is completed, you will be able to eat and drink normally.

If you are having the PET/CT scan first then you will rest for 1 hour during the uptake time, before emptying your bladder and proceeding to have your PET/CT scan which will last approximately 30 minutes. You will then be moved to the PET/MRI scanner and the scan will commence, lasting approximately 1 hour. After completing both scans you will be able to eat and drink normally.

A qualified Nuclear Medicine Physician will interpret the results.
Intervention code [1] 297757 0
Diagnosis / Prognosis
Comparator / control treatment
As part of Radiation Treatment Planning participants will undergo a computed tomography (CT) scan which is the current standard of care scan for planning radiation therapy. This scan will be performed by Radiation Therapists and used for treatment planning by Radiation Oncologists.
Control group
Active

Outcomes
Primary outcome [1] 301732 0
1 Comparison of gross tumour volumes derived from PET/MRI, PET/CT and standard of care.
Timepoint [1] 301732 0
Diagnosis/Treatment Planning
Primary outcome [2] 301802 0
2. Comparison of dosimetry derived from PET/MRI and standard of care.
Timepoint [2] 301802 0
Diagnosis/Treatment Planning
Secondary outcome [1] 333991 0
Assess the accuracy of deformable image registration of PET/MRI to CT simulation data for contouring tumour volumes in radiotherapy treatment planning.
Timepoint [1] 333991 0
Diagnosis/Treatment Planning
Secondary outcome [2] 333992 0
Investigate the feasibility of using PET/MRI data for dose calculations in the radiotherapy treatment planning system. This will be assessed by the proportion of participants in whom dose calculations can be made using PET/MRI data.
Timepoint [2] 333992 0
Diagnosis/Treatment Planning

Eligibility
Key inclusion criteria
Inclusion Criteria
* Patients receiving definitive radiotherapy or chemoradiation for head and neck cancer at the
Royal Brisbane and Women’s Hospital
* Age 18 years and over.
* Willingness to provide written informed consent
* All women of childbearing age must have a pregnancy test before enrolment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
* Patients unable to undergo a PET scan for any reason, in the opinion of the investigator.
* Allergy to FDG
* Pregnant or breastfeeding patients
* Standard MRI exclusion criteria
* Patients with a history of psychological illness or condition such as to interfere with the
patient’s ability to understand the requirements of the study.

Study design
Purpose of the study
Treatment
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296169 0
Hospital
Name [1] 296169 0
Royal Brisbane and Women's Hospital Herston Imaging Research Facility Seed Funding
Address [1] 296169 0
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country [1] 296169 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295073 0
None
Name [1] 295073 0
Address [1] 295073 0
Country [1] 295073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297414 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297414 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 297414 0
Australia
Date submitted for ethics approval [1] 297414 0
28/11/2016
Approval date [1] 297414 0
09/01/2017
Ethics approval number [1] 297414 0

Summary
Brief summary
This study will evaluate the use of PET/CT and PET/MRI imaging for head and neck cancer patients receiving definitive radiation or chemoradiation treatment.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and are receiving definitive radiotherapy or chemoradiation for head and neck cancer at the Royal Brisbane and Women’s Hospital.

Study details
All participants in this study will undergo an additional imaging session at the Herston Imaging Research Facility (HIRF). During the additional imaging session participants will undergo a 18-FDG PET/CT and 18-FDG PET/MRI. You will be asked to fast for up to 6 hours prior to the scan session. A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called FDG.

If you are having the PET/MRI first then the scan will start immediately during the period known as the uptake time. You will be positioned in a way that closely matches your radiation therapy treatment position. The scan involves lying flat with knees and neck supported. The scan time for the FDG PET/MRI is approximately 1 hour. After the examination is completed, you will be asked to empty your bladder and move to the PET/CT scanner where the scan will commence. The exam will take approximately 30 minutes. After the examination is completed, you will be able to eat and drink normally.

If you are having the PET/CT scan first then you will rest for 1 hour during the uptake time, before emptying your bladder and proceeding to have your PET/CT scan which will last approximately 30 minutes. You will then be moved to the PET/MRI scanner and the scan will commence, lasting approximately 1 hour. After completing both scans you will be able to eat and drink normally.

Gross tumour volumes derived from each of the scans will be compared, as will the radiation dose. It is hoped that the new scans will improve our ability to localise cancer more accurately than our current methods, for planning radiation treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73966 0
Prof Lizbeth Kenny
Address 73966 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73966 0
Australia
Phone 73966 0
+61 7 3646 8111
Fax 73966 0
Email 73966 0
lizbeth.kenny@health.qld.gov.au
Contact person for public queries
Name 73967 0
Ms Jacqui Keller
Address 73967 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73967 0
Australia
Phone 73967 0
+61 7 3646 8111
Fax 73967 0
Email 73967 0
jacqui.keller@health.qld.gov.au
Contact person for scientific queries
Name 73968 0
Prof Lizbeth Kenny
Address 73968 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73968 0
Australia
Phone 73968 0
+61 7 3646 8111
Fax 73968 0
Email 73968 0
lizbeth.kenny@health.qld.gov.au