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Completed

NCT Number: NCT04724096

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Enhanced MRI scan

Diagnostic Test

Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.

Primary outcomes

  1. Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique.

    Time frame: 2 years

    Feasibility of OE-MRI scans to detect hypoxic areas within tumours in patients with head and neck squamous cell carcinomas

  2. Association with treatment failure

    Time frame: 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.

Secondary outcomes

  1. Tumour perfusion

    Time frame: 2 years

    Assessment of routinely used diagnostic MRI images to identify non-perfused parts of tumours in combination with oxygen maps

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 26, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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