None listed
Conditions
Brief summary
This study is testing whether an advanced type of MRI scan (called diffusion weighted MRI) can be used to guide and safely increase radiation doses to “high-risk” areas of head and neck cancers, with the aim of improving tumour control while still protecting surrounding healthy tissue. Who is it for? Adults aged 18 years and older with squamous cell carcinoma of the head and neck, or with large nodal metastases suspected to be from the head and neck region, who are not eligible for curative treatment. Participants must be able to give informed consent. Study details Before radiotherapy planning, participants will attend an MRI scan at Sunshine Coast University Hospital, lying in the treatment position with a fitted mask. This scan takes up to one hour. Radiation therapy will then be delivered using the palliative schedule (four treatments per cycle, 3 cycles in total with 1 month gap in between). An extra “boost” dose of radiation will be targeted at the high-risk tumour area identified on the MRI. Each treatment lasts about 15 minutes. Participants will also complete short quality-of-life questionnaires before, during and after treatment (about 10 minutes each). The study will closely monitor side effects during and after radiation treatment. It is hoped that this approach will improve control of head and neck cancers and patient quality of life without adding significant treatment burden.
Interventions
This study aims to assess the feasibility of diffusion weighted magnetic resonance imaging (DW-MRI) guided radiation therapy dose escalation in head and neck cancer (HNC). Participants will need to attend an MRI scan at the Sunshine Coast University Hospital within one to two weeks prior to their standard radiotherapy planning CT, administered by radiographers in the medical imaging department. The MRI is a 1.5T (Tesla) machine, which is one of the most common types of MRI machines used in clini
This study aims to assess the feasibility of diffusion weighted magnetic resonance imaging (DW-MRI) guided radiation therapy dose escalation in head and neck cancer (HNC). Participants will need to attend an MRI scan at the Sunshine Coast University Hospital within one to two weeks prior to their standard radiotherapy planning CT, administered by radiographers in the medical imaging department. The MRI is a 1.5T (Tesla) machine, which is one of the most common types of MRI machines used in clinical practice, offering a balance between detailed image quality, scan time and patient comfort. This scan will be performed with the participant lying in the radiation therapy treatment position with a custom fit immobilisation mask in place and may take up to an hour to perform. Based on the quantitative information from this scan, a high-risk volume within the tumour will be identified. A simultaneous integrated boost (SIB) will be given to palliative quadshot patients of 0.5Gy per fraction to the gross tumour volume (GTV) as defined on the diffusion weighted magnetic resonance image (DW-MRI). Total dose will be 48Gy in 12 treatment fractions to the GTV, given over 4 treatments per cycle, 3 cycles total, with 1 month between each cycle. Each individual treatment takes approximately 15 minutes. Participants will likely only need one MRI, however a repeat MRI may be required to each cycle of treatment over the course of the 3-month treatment. Adherence to the intervention will be checked with review of medical records. The study will be conducted by the Radiation Oncology department at the Sunshine Coast University Hospital in Birtinya, Queensland. The participant will be asked to complete quality of life questionnaires at different timepoints before, during and after the treatment period. These questionnaires may take up to 10 minutes to complete each time. Patients will be monitored closely by the treating team for any acute or late treatment side effects.
Sponsors
Dr Myo Min - Sunshine Coast Hospital and Health Service
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
Either: - Histologically or cytologically proven squamous cell carcinoma from a locally advanced mucosal primary in the head and neck region, or - Massive nodal metastases from an unknown primary suspected to be of head and neck origin - Ineligible for curative treatment on the basis of the extent of their disease and/or general medical condition - 18 years of age or older (no upper limit) - Able to give informed consent to treatment by understanding the nature, significances and consequences of the study
Exclusion criteria
- Life expectancy anticipated to be less than 3 months - Contraindications to MRI such as significant claustrophobia, pacemaker/defibrillator or implanted metals - Claustrophobia preventing utilisation of immobilisation device for radiation therapy planning and treatment - Simultaneous participation in another interventional trial that may interfere with the results of this trial - Pregnancy
Outcome results
None listed