Head and Neck CancerMeRInONCT02497573
Can DW MRI Predict Outcome During Radiotherapy for Head and Neck Cancer?
An observational study of Head and Neck Cancer, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Around 50% of patients with locally advanced H\&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Diffuse Weighted MRI
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate or high risk oropharyngeal squamous cell carcinoma (OPSCC), scheduled to undergo either radiotherapy or chemoradiotherapy as primary treatment in the Beatson West of Scotland Cancer Centre may be suitable for study participation. Suitable patients will be identified at MDT meetings or from the radiotherapy bookings database and approached by the direct clinical care team as they attend for radiotherapy planning appointments. 80 patients will be recruited to the study. Each patient will have at least one target lesion (either lymph node or primary site) for ADC analysis and clinical follow up. MnayMany patients will have 2 or more target lesions. The total number of target lesions is therefore highly likely to be greater than 80.
Who may be able to join
- Histologically confirmed HPV negative SCC oropharynx or patients with HPV positive SCC oropharynx and a significant smoking history
- Stage III or Iva or IVb disease
- Scheduled to undergo radical radiotherapy or chemo radiotherapy as primary treatment
- 18 years of age or older
- Able to give written informed consent
- Patients willing and able to comply with the protocol for the duration of the study
- HPV status: As defined by the Scottish HPV reference laboratory, multiplex assay on Luminex technology Significant smoking history definition: greater than 10 pack years
Who cannot join
- Head and neck cancers from sub sites other than oropharynx
- HPV+OPSCC in patients with no significant smoking history (low risk OPSCC)
- Patients receiving cetuximab-radiotherapy
- Confirmed distal metastatic disease (stage IVc)
- Patients who have undergone primary surgery for SCC H\&N, neck dissection alone permitted
- Patients who have received induction chemotherapy prior to definitive treatment
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- Patients with contra-indications to MRI scanning
- Contra-indications to MRI:
- As per standard diagnostic imaging protocol - cardiac pacemaker, surgery within 8 weeks, aneurysm clipped/treated, metal fragments in eye, previous cranial surgery, any metal in the body.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Dr C Paterson, MB ChB, 440141 30107045, claire.paterson2@ggc.scot.nhs.uk
About this study
Official title: Study of Diffusion Weighted MRI as a Predictive Biomarker of Response During Radiotherapy for High and Intermediate Risk Squamous Cell Cancer of the Oropharynx (MeRInO Study)
Around 50% of patients with locally advanced H\&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders.
This study is designed to assess the value of DW MRI as a predictive biomarker of response to radiotherapy in intermediate and high risk OPSCC.
Read the detailed description
Around 1000 patients with new cancers of the head and neck (H\&N) are registered in Scotland annually. Approximately 60% of these are managed in the west of Scotland. Unfortunately a large proportion, around 60%, of H\&N cancers present with locally advanced but non-metastatic disease. These are associated with poor outcomes with 3 year survival around 50%. Despite intensive radical therapy associated with significant acute toxicity, there is a high recurrence rate (up to 50%) and unlike many other cancers, the vast majority of these recurrences, around 80%, occur locally and many patients go on to die from their local disease without developing distant metastases. Locally recurrent tumours cause significant morbidity and palliation is difficult. There is a therefore a clear need to further improve local disease control, both to increase cure rates and to improve quality of life.
This study is designed to assess the value of DW MRI as a predictive biomarker in intermediate and high risk OPSCC. DW MRI and changes in ADC have been shown to correlate with response to treatment in prospective and retrospective studies in SCC H\&N. These studies have included all H\&N sub-sites with no differentiation between biological sub-types. This study may therefore validate the use of DW MRI as a predictive biomarker specifically in the intermediate and high risk groups of OPSCC. If change in ADC during RT is found to be predictive of eventual clinical outcome and a discriminatory threshold rise in ADC identified, this information could be used to inform treatment intensification in patients responding poorly to RT. This would form the basis of subsequent clinical trials.
The hypothesis of this study is that quantitative DW MRI - i.e. change in ADC during RT - is predictive of locoregional control in intermediate and high risk OPSCC and that a threshold can be identified in ADC change that will discriminate responders from non-responders to radiotherapy.
The design is a single centre observational study to assess the value of DW MRI as a predictive biomarker in HPV-OPSCC. 2 DW MRI scans will be carried out on participants in addition to all standard imaging and procedures for radiotherapy. The information gained from the MRI scans will not be used to change standard treatment for these patients. DW MRI_1 will be obtained prior to radiotherapy commencing. DW MRI_2 will be carried out during the third week of radiotherapy treatment. The DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. The MRI scans will be carried out during routine hospital visits for radiotherapy planning and treatment therefore will involve no extra visits for participants.
After completion of (chemo) radiotherapy, patients will attend the Beatson WoSCC for follow up visits as per standard protocol at 3, 6, 12, 18 months post treatment. Information regarding recurrence will be collected at these routine visits. No extra post-treatment visits are therefore required from participants.
The recruitment phase is estimated to last for 2 years and patients will be followed up will be for 18 months after completion of radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Diffuse Weighted MRI
- 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.
Diffuse Weighted MRIOther
The DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. Each scan will take approximately 30 minutes. Images will be acquired and analysed as per the separate scanning protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in composite ADC
Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparison with MRI1
Measured: 3 weeks
Relapse status
Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.
Measured: 18 months
Secondary outcomes (1)
Time to Relapse
If relapse occurs (failure), the time to relapse, from baseline, will be recorded. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.
Measured: Up to 22 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startMay 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Paterson, PhD, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497573
- Sponsor's protocol ID
- GN15ON249
- Acronym
- MeRInO
- Status last verified
- Nov 2016
- First submitted
- 6 Jul 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Diffusion Weighted MRI as a Predictive Biomarker of Response During Radiotherapy for High and Intermediate Risk Squamous Cell Cancer of the Oropharynx (MeRInO Study)
- ClinicalTrials.gov ID
- NCT02497573
- Acronym / sponsor ID
- MeRInO / GN15ON249
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Around 50% of patients with locally advanced H\&N cancer fail to achieve loco-regional control. Currently it cannot be predicted, during treatment, who will fall into this group of non-responders.
This study is designed to assess the value of DW MRI as a predictive biomarker of response to radiotherapy in intermediate and high risk OPSCC.
Detailed description
Around 1000 patients with new cancers of the head and neck (H\&N) are registered in Scotland annually. Approximately 60% of these are managed in the west of Scotland. Unfortunately a large proportion, around 60%, of H\&N cancers present with locally advanced but non-metastatic disease. These are associated with poor outcomes with 3 year survival around 50%. Despite intensive radical therapy associated with significant acute toxicity, there is a high recurrence rate (up to 50%) and unlike many other cancers, the vast majority of these recurrences, around 80%, occur locally and many patients go on to die from their local disease without developing distant metastases. Locally recurrent tumours cause significant morbidity and palliation is difficult. There is a therefore a clear need to further improve local disease control, both to increase cure rates and to improve quality of life.
This study is designed to assess the value of DW MRI as a predictive biomarker in intermediate and high risk OPSCC. DW MRI and changes in ADC have been shown to correlate with response to treatment in prospective and retrospective studies in SCC H\&N. These studies have included all H\&N sub-sites with no differentiation between biological sub-types. This study may therefore validate the use of DW MRI as a predictive biomarker specifically in the intermediate and high risk groups of OPSCC. If change in ADC during RT is found to be predictive of eventual clinical outcome and a discriminatory threshold rise in ADC identified, this information could be used to inform treatment intensification in patients responding poorly to RT. This would form the basis of subsequent clinical trials.
The hypothesis of this study is that quantitative DW MRI - i.e. change in ADC during RT - is predictive of locoregional control in intermediate and high risk OPSCC and that a threshold can be identified in ADC change that will discriminate responders from non-responders to radiotherapy.
The design is a single centre observational study to assess the value of DW MRI as a predictive biomarker in HPV-OPSCC. 2 DW MRI scans will be carried out on participants in addition to all standard imaging and procedures for radiotherapy. The information gained from the MRI scans will not be used to change standard treatment for these patients. DW MRI_1 will be obtained prior to radiotherapy commencing. DW MRI_2 will be carried out during the third week of radiotherapy treatment. The DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. The MRI scans will be carried out during routine hospital visits for radiotherapy planning and treatment therefore will involve no extra visits for participants.
After completion of (chemo) radiotherapy, patients will attend the Beatson WoSCC for follow up visits as per standard protocol at 3, 6, 12, 18 months post treatment. Information regarding recurrence will be collected at these routine visits. No extra post-treatment visits are therefore required from participants.
The recruitment phase is estimated to last for 2 years and patients will be followed up will be for 18 months after completion of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate or high risk oropharyngeal squamous cell carcinoma (OPSCC), scheduled to undergo either radiotherapy or chemoradiotherapy as primary treatment in the Beatson West of Scotland Cancer Centre may be suitable for study participation. Suitable patients will be identified at MDT meetings or from the radiotherapy bookings database and approached by the direct clinical care team as they attend for radiotherapy planning appointments. 80 patients will be recruited to the study. Each patient will have at least one target lesion (either lymph node or primary site) for ADC analysis and clinical follow up. MnayMany patients will have 2 or more target lesions. The total number of target lesions is therefore highly likely to be greater than 80.
Key inclusion criteria (7 listed)
- Histologically confirmed HPV negative SCC oropharynx or patients with HPV positive SCC oropharynx and a significant smoking history
- Stage III or Iva or IVb disease
- Scheduled to undergo radical radiotherapy or chemo radiotherapy as primary treatment
- 18 years of age or older
- Able to give written informed consent
Key exclusion criteria (9 listed)
- Head and neck cancers from sub sites other than oropharynx
- HPV+OPSCC in patients with no significant smoking history (low risk OPSCC)
- Patients receiving cetuximab-radiotherapy
- Confirmed distal metastatic disease (stage IVc)
- Patients who have undergone primary surgery for SCC H\&N, neck dissection alone permitted
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 |
|---|---|---|
| Diffuse Weighted MRIThe DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. Each scan will take approximately 30 minutes. Images will be acquired and analysed as per the separate scanning protocol. | Other | – |
Primary outcome
change in composite ADC
Time frame: 3 weeks
Apparent Diffusion Coefficient measured at each MRI for each target lesion and the % change in each target lesion will be recorded at MRI2, in comparison with MRI1
Relapse status
Time frame: 18 months
Relapse status (control or failure), for each target lesion, will be recorded at the 18 month time point and compared with baseline. Control is defined as absence of any new mass, serial reduction in size or unchanged size of residual mass. Failure is defined as biopsy proven recurrence, new mass or serial increase in size of residual mass.
1 secondary outcome
Time to Relapse
Time frame: Up to 22 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- 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.
Claire Paterson, PhD principal investigator
NHS Greater Glasgow and Clyde
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 Cancer, run by NHS Greater Glasgow and Clyde 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 7 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Dearie, BSc (HONS) (+44 (0)141 211 2195 ext. 2195, paul.dearie@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in composite ADC (time frame: 3 weeks). 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?
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 2 Nov 2016.