None listed
Conditions
Brief summary
This study will evaluate the role of magnetic resonance imaging (MRI) in the treatment of Mucosal Primary Head and Neck Cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or suspect tumours for mucosal primary head and neck cancer. Study details: Imaging studies are not routinely performed during radiotherapy for head and neck cancer. In this study, all participants will receive multiple additional MRI sequences before, during and after radiotherapy treatment (with or without chemotherapy). MRI sequences used include DWI, R2*, and DCE. The results from all scans will be evaluated with respect to tumour response, local control, disease free survival and overall survival. The main purpose of this study is to see whether new MRI techniques during and after radiotherapy treatment provides the doctors with accurate information which predicts the later response of mucosal primary head and neck cancer to the treatment and also evaluates tumour recurrence following treatment.
Interventions
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 flo
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.
Sponsors
Dr Myo Min
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed