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

Sponsor
Nottingham University Hospitals NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04724096
Collaborator
(none)
55
Enrollment
1
Location
23
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer
Actual Study Start Date :
Mar 4, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Secondary Outcome Measures

  1. Tumour perfusion [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queens Medical Centre Nottingham Nottinghamshire United Kingdom NG7 2UH

Sponsors and Collaborators

  • Nottingham University Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04724096
Other Study ID Numbers:
  • 20MP001
First Posted:
Jan 26, 2021
Last Update Posted:
Mar 26, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nottingham University Hospitals NHS Trust
Oxygen enhanced MRI
Additional relevant MeSH terms:
Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Mar 26, 2021