NCT04724096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

January 21, 2021

Last Update Submit

May 3, 2023

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Oxygen enhanced MRI

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Tumour perfusion

    2 years

Study Arms (2)

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

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

Interventions

Oxygen Enhanced MRI scanDIAGNOSTIC_TEST

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

Non-patient volunteersPatients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 18 years and above
  • Signed written informed consent
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

  • McCabe A, Martin S, Rowe S, Shah J, Morgan PS, Borys D, Panek R. Oxygen-enhanced MRI assessment of tumour hypoxia in head and neck cancer is feasible and well tolerated in the clinical setting. Eur Radiol Exp. 2024 Mar 6;8(1):27. doi: 10.1186/s41747-024-00429-1.

    PMID: 38443722DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Rafal Panek, PhD

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 26, 2021

Study Start

March 4, 2021

Primary Completion

November 28, 2022

Study Completion

February 1, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)