Evaluation of OE-MRI in Patients With H&N Cancer

NHS Trust

Status: Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Diagnostic Test: Oxygen Enhanced MRI scan

Study type: Observational

Funder types: Other

Identifiers

NCT04724096

20MP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

25 participants in 2 patient groups

Non-patient volunteers

Description:

5 non-patient volunteers for testing of protocol to allow for the ascertaining of good quality data prior to the scanning of patients.

Treatment:

Diagnostic Test: Oxygen Enhanced MRI scan

Patients

Description:

50 patients to be scanned with the oxygen enhanced MRI scan protocol prior to definitive curative intent therapy.

Treatment:

Diagnostic Test: Oxygen Enhanced MRI scan