Head and Neck CancerNCT03646747
Oxygen Enhanced MRI Measurement in Head and Neck Cancer: Validation and Efficacy of Response.
A study testing MRI scan in people with Head and Neck Cancer, run by Sally Falk.
Trial summary
This is a prospective pilot study to investigate the potential clinical value of oxygen-enhanced magnetic resonance (OE-MRI) biomarkers in head and neck radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Able to receive and understand verbal and written information regarding the study and given written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30mL/min
- Be able to lie comfortably on back for up to 1 hour
- Be able to tolerate a thermoplastic shell
Show all 10Show fewer
- Female patients must meet one of the following criteria:
- Postmenopausal for a minimum of one year ii. Surgically sterile iii. Not pregnant, confirmed by B-HCG blood test. iv. Not breastfeeding
- Cohort A (healthy participants): Up to 10 will be recruited to validate the use of nasal cannula
- Cohort B (patients): Any patient with HNSCC who is due to start definitive radiotherapy +/- chemotherapy. Up to 30 will be recruited. Each patient prior to recruitment will undergo a diagnostic biopsy at their local hospital as standard of care. The formalin fixed paraffin embedded (FFPE) tumour biopsy sample blocks will be requested from each site and stored in the Manchester Cancer Research Centre (MRCR) and tested for a multi-gene signature.
Who cannot join
- Healthy volunteers or patients with any contraindications to MRI scanning (i.e heart valve replacement, pacemaker, metal implants not approved for MRI, neurostimulators), history of contrast (Gadolinium) allergy or pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective pilot study to investigate the potential clinical value of oxygen-enhanced magnetic resonance (OE-MRI) biomarkers in head and neck radiotherapy.
Read the detailed description
This is a prospective pilot study funded by the NIHR. Healthy participants and patients will be recruited in The Christie NHS Foundation Trust and will be asked to undergo oxygen-enhanced magnetic resonance imaging (OE-MRI) and dynamic contrast-enhanced MRI (DCE-MRI). This study builds on the work recently been completed in lung cancer. Clinical data will be collected from patients notes.
Tumour hypoxia is common in solid tumours and associated with poor response to radiotherapy, poor loco-regional control and survival outcomes in head and neck cancer. There is a need to develop non-invasive tests that can measure tumour hypoxia to improve radiotherapy for these patients. The study will involve 3 components:
- Reproducibility and feasibility: The reproducibility of OE-MRI in head and neck cancer is unknown. Ten healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout. The order of which non-invasive breathing method will be used first will be randomized. Following this initial pilot OE-MRI will be tested in 30 patients with solid head and neck tumours. To assess reproducibility in patients 2 OE-MRI will be performed at baseline.
- Effect of radiotherapy on tumour and normal tissue: OE-MRI and DCE-MRI signals will be measured at baseline before standard radiotherapy treatment begins and at the end of week 2 week and week 4 following the start of radiotherapy. Comparison of hypoxia measurements will be taken.
- Biological validation: All 30 patients will undergo a diagnostic biopsy as standard of care at their local hospital. Tissue samples will be requested and multi-gene hypoxia signatures will be tested. OE-MRI signals will be compared with tissue sample from the same patient and the presence of changes in tumour known to be associated with hypoxia will be analysed.
- Conditions
- Head and Neck Cancer
- Being tested
- MRI scan
- Keywords
- head and neck, radiotherapy, magnetic resonance imaging
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
Additional imaging using MRI scan
| Study group | Role | What they receive |
|---|---|---|
| MRI scan | Experimental | 10 healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout.
Following this initial pilot, OE-MRI will be tested in 30 patients with solid head and neck tumours. Receives: Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)
Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)
Measured: 3 years
Secondary outcomes (4)
Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation.
Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation.
Measured: 3 years
Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy
Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy
Measured: 3 years
Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion
Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion
Measured: 3 years
Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer
Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single site, non-randomised basic science study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sally Falk
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor-investigator, Sally Falk, The Christie NHS Foundation Trust
- Investigators
- James O'Connor, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646747
- Sponsor's protocol ID
- 18_RADIO_133
- Status last verified
- Aug 2018
- First submitted
- 3 May 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Enhanced MRI Measurement in Head and Neck Cancer: Validation and Efficacy of Response.
- ClinicalTrials.gov ID
- NCT03646747
- Acronym / sponsor ID
- 18_RADIO_133
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck, radiotherapy, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sally FalkUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Aug 2018 (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.
This is a prospective pilot study to investigate the potential clinical value of oxygen-enhanced magnetic resonance (OE-MRI) biomarkers in head and neck radiotherapy.
Detailed description
This is a prospective pilot study funded by the NIHR. Healthy participants and patients will be recruited in The Christie NHS Foundation Trust and will be asked to undergo oxygen-enhanced magnetic resonance imaging (OE-MRI) and dynamic contrast-enhanced MRI (DCE-MRI). This study builds on the work recently been completed in lung cancer. Clinical data will be collected from patients notes.
Tumour hypoxia is common in solid tumours and associated with poor response to radiotherapy, poor loco-regional control and survival outcomes in head and neck cancer. There is a need to develop non-invasive tests that can measure tumour hypoxia to improve radiotherapy for these patients. The study will involve 3 components:
- Reproducibility and feasibility: The reproducibility of OE-MRI in head and neck cancer is unknown. Ten healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout. The order of which non-invasive breathing method will be used first will be randomized. Following this initial pilot OE-MRI will be tested in 30 patients with solid head and neck tumours. To assess reproducibility in patients 2 OE-MRI will be performed at baseline.
- Effect of radiotherapy on tumour and normal tissue: OE-MRI and DCE-MRI signals will be measured at baseline before standard radiotherapy treatment begins and at the end of week 2 week and week 4 following the start of radiotherapy. Comparison of hypoxia measurements will be taken.
- Biological validation: All 30 patients will undergo a diagnostic biopsy as standard of care at their local hospital. Tissue samples will be requested and multi-gene hypoxia signatures will be tested. OE-MRI signals will be compared with tissue sample from the same patient and the presence of changes in tumour known to be associated with hypoxia will be analysed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single site, non-randomised basic science study
| Arm | Type | Receives |
|---|---|---|
| MRI scan | Experimental | Diagnostic Test: MRI scan10 healthy participants will be asked to undergo two baseline OE-MRI scans with either nasal cannula or facial mask to breathe air and oxygen throughout. Following this initial pilot, OE-MRI will be tested in 30 patients with solid head and neck tumours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 or over
- Able to receive and understand verbal and written information regarding the study and given written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30mL/min
- Be able to lie comfortably on back for up to 1 hour
Key exclusion criteria (1 listed)
- Healthy volunteers or patients with any contraindications to MRI scanning (i.e heart valve replacement, pacemaker, metal implants not approved for MRI, neurostimulators), history of contrast (Gadolinium) allergy or pregnancy.
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 |
|---|---|---|
| MRI scanAdditional imaging using MRI scan | Diagnostic test | MRI scan |
Primary outcome
Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)
Time frame: 3 years
Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences)
4 secondary outcomes
Optimal MRI sequence to image participants with head and neck cancer, based on tumour and organ at risk visualisation.
Time frame: 3 years
Treatment response in a number of participants with head and neck cancer treated with radiotherapy +/- systemic therapy
Time frame: 3 years
Treatment related toxicities in a number of participants with head and neck cancer as assessed during and after treatment completion
Time frame: 3 years
Survival outcomes in a number of participants treated with radiotherapy +/- systemic therapy for head and neck cancer
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Individual participant dataSharing planned: No
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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.
James O'Connor principal investigator
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Head and Neck Cancer, run by Sally Falk.
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 10 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Falk (0044 161 446 8318 ext. 8318, sally.falk@christie.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hypoxia in head and neck squamous cell cancer using oxygen enhanced Magnetic resonance imaging (using a range of different MR sequences) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018.