Head and Neck Squamous Cell CarcinomaNCT04724096
Evaluation of OE-MRI in Patients With H&N Cancer
An observational study of Head and Neck Squamous Cell Carcinoma, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Oxygen Enhanced MRI scan
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2021to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 5 non-patient volunteers. 50 patients from Nottingham University Hospitals NHS Trust, UK.
Who may be able to join
- 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
Show all 9Show fewer
- Age 18 years and above
- Adequate physical fitness (WHO performance status 0 to 2)
- Signed written informed consent
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Oxygen Enhanced MRI scan
- Keywords
- Oxygen enhanced MRI
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Enhanced MRI scanDiagnostic test
Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Oxygen Enhanced MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (1)
Tumour perfusion
Assessment of routinely used diagnostic MRI images to identify non-perfused parts of tumours in combination with oxygen maps
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start4 Mar 2021
- Primary completion28 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafal Panek, PhD, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724096
- Sponsor's protocol ID
- 20MP001
- Status last verified
- May 2023
- First submitted
- 21 Jan 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38443722
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04724096
- Acronym / sponsor ID
- 20MP001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Oxygen enhanced MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-patient volunteers | – | Diagnostic Test: Oxygen Enhanced MRI scan5 non-patient volunteers for testing of protocol to allow for the ascertaining of good quality data prior to the scanning of patients. |
| Patients | – | Diagnostic Test: Oxygen Enhanced MRI scan50 patients to be scanned with the oxygen enhanced MRI scan protocol prior to definitive curative intent therapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 5 non-patient volunteers. 50 patients from Nottingham University Hospitals NHS Trust, UK.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen Enhanced MRI scanDynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan. | Diagnostic test | Non-patient volunteers, Patients |
Primary outcome
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
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.
1 secondary outcome
Tumour perfusion
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38443722McCabe 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.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafal Panek, PhD principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.