Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000534482
Ethics application status
Approved
Date submitted
6/04/2016
Date registered
26/04/2016
Date last updated
16/08/2022
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the role of Magnetic resonance Imaging (MRI) in Mucosal Primary Head and Neck Cancer
Scientific title
Evaluation of the Role Of Magnetic Resonance Imaging (MRI) in Mucosal Primary Head and Neck Cancer
Secondary ID [1] 288939 0
Nil
Universal Trial Number (UTN)
U1111-1181-6110
Trial acronym
MRI in MPHNC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 298302 0
Condition category
Condition code
Cancer 298428 298428 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved in this study is seven additional MRI scans of approximately 45 minutes in length for each scan. These scans will involve the use of a contrast agent administered by the treating doctor. The MRI scan will be performed by a suitably qualified allied health professional using three MRI sequences. These sequences are all investigational sequences and include DCE, DWI, and R2*.
DCE MRI is Dynamic contrast-enhanced MRI and gives information about tissue and tumour blood flow.
DWI is Diffusion weighted imaging MRI and gives information about the degree of cellularity or density of cells.
R2* is a type of MRI sequence that gives information about the level of oxygenation within the tumour.
These scans will be performed before, during and in the follow up stage after radiotherapy treatment over approximately a 4 month period. This includes MRI scans performed one week prior to radiotherapy treatment, 4 times during radiotherapy treatment one week apart (either directly before or after the daily treatment in treatment week 2, 3, 5 and 6) and then week 4 and week 12 after radiotherapy treatment is finished.
ALL MRI scans performed before, during or after the radiotherapy treatment are only for treatment response prediction. These scans are not being performed for the purpose of diagnostic accuracy.
For the standard PET-CT and investigational MRI scan performed prior to radiotherapy treatment, week 3 during radiotherapy treatment and at 12 weeks after radiotherapy treatment, these will be performed within a few days of each other at the same hospital but in different departments. All other investigational MRI scans will be performed on the same day as either radiotherapy treatment or the routine clinic visit.
This study will evaluate the use of different current clinically released and new research MRI sequences, before, during and after radiotherapy treatment in predicting prognosis and tumour response for head and neck cancer.
Intervention code [1] 294419 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - all patients will receive the same investigations including standard scans (PET-CT) and investigational scans (MRI).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297917 0
To determine the correlation of pre-, during treatment and post-radiotherapy (+/- chemotherapy) MRI sequences with respect to tumour response at 3 months by PET scan and local control at 12 months which will be determined through radiological assessment (PET scan), physical examination and flexible naso-endoscopy examination.
Timepoint [1] 297917 0
3 and 12 months post radiotherapy treatment
Secondary outcome [1] 322623 0
To prospectively correlate different MRI sequences and FDG-PET findings with disease free survival (DFS)
Timepoint [1] 322623 0
12, 18, 24, 30 and 36 months post radiotherapy
Secondary outcome [2] 322624 0
To determine the best time to perform a MRI during radiotherapy treatment for assessing tumour response and local control by assessment through radiological assessment (PET scan), physical examination and flexible naso-endoscopy examination.
Timepoint [2] 322624 0
End of radiotherapy treatment
Secondary outcome [3] 322625 0
To determine the sensitivity and specificity of DW MRI sequence in comparison with FDG-PET in assessment of potential residual and recurrent mucosal primary head and neck cancer following definitive radiotherapy
Timepoint [3] 322625 0
3 months post treatment
Secondary outcome [4] 322626 0
To determine the accuracy of MR-only treatment planning in comparison with the current radiotherapy gold standard of CT planning that will be assessed through comparison of treatment plans using MR only compared to CT only. This will be assessed specifically by evaluating contouring of tumour and healthy organs and evaluation of dose prescription and accuracy of dose calculation in both MR and CT calculated plans.
Timepoint [4] 322626 0
Prior to radiotherapy treatment during radiotherapy planning
Secondary outcome [5] 323016 0
To prospectively correlate different MRI sequences and FDG-PET findings with overall survival (OS) . OS will be assessed at routine clinical follow up visits.
Timepoint [5] 323016 0
12, 18, 24, 30 and 36 months post radiotherapy
Secondary outcome [6] 323017 0
To determine the sensitivity and specificity of R2* MRI sequence in comparison with FDG-PET in assessment of potential residual and recurrent mucosal primary head and neck cancer following definitive radiotherapy
Timepoint [6] 323017 0
3 months post treatment
Secondary outcome [7] 323018 0
To determine the sensitivity and specificity of DCE MRI sequence in comparison with FDG-PET in assessment of potential residual and recurrent mucosal primary head and neck cancer following definitive radiotherapy
Timepoint [7] 323018 0
3 months post treatment

Eligibility
Key inclusion criteria
- 18 years or older
- Have the ability to give informed consent
- Histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or patients with tumours strongly suspicious for mucosal primary head and neck cancer due to clinical features AND fine needle aspiration (FNA) cytology assessment
- Primary mucosal head and neck cancer (greater than or equal to T2 and/or greater than or equal to N1) AND no evidence of metastatic disease on staging PET/CT or CT (chest +/- abdomen +/- pelvis)
- Patient undergoing curative intent primary radiotherapy +/- chemotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to MRI studies including significant claustrophobia, pacemaker/implantable defibrillator, implanted metals eg. Intraocular clips, and/or known allergic reaction to Gadolinium (Gd)-DTPA
- Previous radiotherapy and/or surgery in the head and neck region
- Other malignancy (history of malignancy within 5 years)
- Pregnant

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/04/2016
Actual
16/06/2016
Date of last participant enrolment
Anticipated
31/12/2022
Actual
19/02/2020
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
55
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5581 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 5582 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 13034 0
2170 - Liverpool
Recruitment postcode(s) [2] 13035 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 293298 0
Hospital
Name [1] 293298 0
Liverpool Cancer Services Trust Fund
Country [1] 293298 0
Australia
Primary sponsor type
Individual
Name
Dr Myo Min
Address
Liverpool Cancer Therapy Centre
1 Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 292103 0
None
Name [1] 292103 0
Address [1] 292103 0
Country [1] 292103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294773 0
South Western Sydney Local Health District
Ethics committee address [1] 294773 0
Ethics committee country [1] 294773 0
Australia
Date submitted for ethics approval [1] 294773 0
23/06/2014
Approval date [1] 294773 0
27/08/2014
Ethics approval number [1] 294773 0
HREC/14/LPOOL/301

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62434 0
Dr Mark Lee
Address 62434 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 62434 0
Australia
Phone 62434 0
+61 (02) 8738 9806
Fax 62434 0
+61 (02) 8738 5299
Email 62434 0
Mark.Lee2@health.nsw.gov.au
Contact person for public queries
Name 62435 0
Mark Lee
Address 62435 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 62435 0
Australia
Phone 62435 0
+61 (02) 8738 9806
Fax 62435 0
+61 (02) 8738 5299
Email 62435 0
Mark.Lee2@health.nsw.gov.au
Contact person for scientific queries
Name 62436 0
Mark Lee
Address 62436 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 62436 0
Australia
Phone 62436 0
+61 (02) 8738 9806
Fax 62436 0
+61 (02) 8738 5299
Email 62436 0
Mark.Lee2@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed to show trends within the cohort


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
SourceTitleYear of PublicationDOI
EmbaseMultiparametric magnetic resonance imaging in mucosal primary head and neck cancer: A prospective imaging biomarker study.2017https://dx.doi.org/10.1186/s12885-017-3448-5
EmbaseImpact of tumour region of interest delineation method for mid-treatment FDG-PET response prediction in head and neck squamous cell carcinoma undergoing radiotherapy.2023https://dx.doi.org/10.21037/qims-22-798
N.B. These documents automatically identified may not have been verified by the study sponsor.