Clinical trial NCT04724096: Evaluation of OE-MRI in Patients With H&N Cancer
Official title: Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Oxygen enhanced MRI
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 non-patient volunteers. 50 patients from Nottingham University Hospitals NHS Trust, UK.

Brief summary: Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.

Detailed description: Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.

Eligibility criteria: Inclusion Criteria:

Non-patient Volunteer Inclusion Criteria:

* Age 18 years and above
* Signed written informed consent

Patient Inclusion Criteria:

* Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck
* Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT
* Age 18 years and above
* Adequate physical fitness (WHO performance status 0 to 2)
* Signed written informed consent

Exclusion Criteria:

Non-patient Volunteer Exclusion Criteria:

* Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol

Patient Exclusion Criteria:

* Poor physical fitness (WHO performance status greater than 2)
* Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol
* Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen
* Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol

Primary outcomes:
measure: Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique.
timeFrame: 2 years
measure: Association with treatment failure
timeFrame: 2 years
Secondary outcomes:
measure: Tumour perfusion
timeFrame: 2 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Rafal Panek, PhD
role: PRINCIPAL_INVESTIGATOR
References: