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

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT04724096
• Lead Sponsor: Nottingham University Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Study Start: 2021-03-04
• Primary Completion: 2022-11-28
• Study Completion: 2023-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association with treatment failure	2 years	Test predictive value of OE-MRI to identify patients with the highest risk of treatment failure and provide data to allow a power calculation for a larger future trial of the predictive power of OE-MRI for treatment outcomes in head and neck cancer treated with radiotherapy.
Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique.	2 years	Feasibility of OE-MRI scans to detect hypoxic areas within tumours in patients with head and neck squamous cell carcinomas

Secondary Outcome Measures

Name	Time	Method
Tumour perfusion	2 years	Assessment of routinely used diagnostic MRI images to identify non-perfused parts of tumours in combination with oxygen maps

Trial Locations

Locations (1)

Queens Medical Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom