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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724096
• Other study ID #: 20MP001
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2023
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2023
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• Oxygen Enhanced MRI scan
Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

Locations

Country	Name	City	State
United Kingdom	Queens Medical Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tumour perfusion	Assessment of routinely used diagnostic MRI images to identify non-perfused parts of tumours in combination with oxygen maps	2 years