Specialty: Cancer, Primary sub-specialty: Head and Neck Cancer
Conditions
Interventions
This is an observational study to assess novel MRI imaging techniques T1 and T2* with supplemental oxygen and carbogen breathing and CEST. Baseline scans will be compared to imaging during and post tr
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. HPV-positive oropharyngeal squamous cell carcinoma for treatment with radical radiotherapy +/- systemic therapy 4. The tumour is at least T2 or if nodal disease is used as the treatment assessment site, the node is at least 2 cm in minimum diameter on MRI 5. In the Investigator’s opinion, is able and willing to comply with all study requirements 6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study 7. Involvement in other clinical studies is acceptable
Exclusion criteria
Exclusion criteria: 1. Female participant who is pregnant, lactating or planning pregnancy during the course of the study 2. Significant renal or hepatic impairment 3. Type 1 diabetes mellitus or poorly controlled T2 diabetes mellitus or fasting capillary/venous blood glucose level > 8mmol/L. 4. Ongoing supplemental oxygen as part of clinical care 5. Known lung disease with carbon dioxide retention, chronic obstructive airways disease with known or at risk of hypercapnia 6. Most recent available arterial blood gas (ABG) from the current hospital admission demonstrates hypoxia or hypercapnia on room air 7. Any patient not felt to be suitable for supplemental oxygen or carbogen as considered by an appropriately trained clinician 8. Contraindication to MRI (e.g. cardiac pacemaker, ferromagnetic cerebral aneurysm clip, metallic foreign body in the eye) 9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in tumour T1 and T2* imaging with supplemental oxygen at baseline, week 2 radiotherapy and 10 weeks post radiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CEST signal with and without supplemental oxygen, measured at baseline, week 2 RT and 10 weeks post RT 2. T1, T2* and CEST signal with supplemental carbogen, measured at baseline, week 2 RT and 10 weeks post RT 3. Changes in GlucoCEST pre & post glucose load and markers such as choline, creatine, lactate, APT, measured at baseline, week 2 RT and 10 weeks post RT 4. FDG-PET parameters including SUVmax, uptake volume, measured at baseline and 10 weeks post RT 5. Standard DCE-MRI parameters such as ktrans, Ve, AUC compared with dynamic glucoCEST signal changes such as AUC, measured at baseline, week 2 RT and 10 weeks post RT 6. Consistency of MRI parameter measurements, evaluated using test-retest imaging at baseline in a subgroup of participants | — |
Countries
United Kingdom
Outcome results
None listed