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

Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Diagnostic test: Oxygen Enhanced MRI scan

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Queens Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

5 non-patient volunteers. 50 patients from Nottingham University Hospitals NHS Trust, UK.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-patient volunteers; 5 non-patient volunteers for testing of protocol to allow for the ascertaining of good quality data prior to the scanning of patients.	Diagnostic test: Oxygen Enhanced MRI scan; Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.
Patients; 50 patients to be scanned with the oxygen enhanced MRI scan protocol prior to definitive curative intent therapy.	Diagnostic test: Oxygen Enhanced MRI scan; Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique.	Feasibility of OE-MRI scans to detect hypoxic areas within tumours in patients with head and neck squamous cell carcinomas	2 years
Association with treatment failure	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.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Rafal Panek, PhD, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Oxygen enhanced MRI
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 20MP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No