Head and Neck Cancer
Conditions
Keywords
Head, Neck, Cancer, PET MRI
Brief summary
The primary research question to be answered in this project is Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell? This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan. The secondary question is Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by: 1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan. 2. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.
Interventions
DIAGNOSTIC_TESTPET-MRI
Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or over 2. Able to give informed written consent. 3. New diagnosis of biopsy-proven head and neck cancer. 4. WHO performance status ≤ 2. 5. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy. 6. MRI and PET-CT staging scans for diagnosis.
Exclusion criteria
1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents. 2. Claustrophobia or other contraindications to MRI. 3. Unable to pass through a 55 cm hula hoop. 4. Female patients that are pregnant or breastfeeding. 5. Unable to understand written or spoken English. 6. Patients not undergoing radical intent radiotherapy. 7. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of PET-MRI | 12 months | To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of additional PET-MRI on radiotherapy target volumes | 12 months | The secondary objective is to compare the radiotherapy target volumes between conditions (with vs without the use of PET-MRI scan) |
| Impact of additional PET-MRI on treatment plan | 12 months | Assess inter- and intra-observer variability in treatment contours and precision of target delineation in the three categories above (CT, CT-MRI, and CT-PET-MRI scans). This will be assessed using Hausdorff distance in the three categories. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Added benefit to diagnostic investigations | 12 months | Clinical reports of the PET-MRI scan will be compared to reports from staging MRI and PET-CT scans to determine if any new diagnostic information is brought to light by PET-MRI. |
Countries
United Kingdom
Contacts
Primary ContactDominic Nash
Backup ContactSatya Garikipati, MD
Outcome results
None listed