Head and Neck CancerNCT02273778
MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer
A study testing MRI Scan and PET-CT Scan in people with Head and Neck Cancer, run by The Leeds Teaching Hospitals NHS Trust.
Trial summary
Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MRI Scan and PET-CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2013
- 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 to 100 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age ≥18
- WHO Performance status 02
- Histologically proven squamous cell carcinoma of the head and neck region
- Clinical decision made to proceed with a course of radiotherapy of curative intent of 6670Gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy
- Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
- Able to provide fully informed written consent
- Able to lie flat for 1 hour
- Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.
Who cannot join
- Hypersensitivity to fluorine-18 FDG
- Hypersensitivity to iodinated contrast media or Gadolinium
- Poorly controlled diabetes
- Acute renal failure or moderate renal impairment (estimated glomerularb filtration rate < 30 mL/min)
- Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
- Claustrophobia precluding MRI imaging
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- Uncontrolled pain
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric comorbidity
About this study
Official title: A Pilot Study Investigating the Use of Co-registered 18FDG-PET-CT and MRI for Radiotherapy Planning in Locally Advanced Head and Neck Squamous Cell Carcinoma
Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. The investigators know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be directly planned on these types of scans. The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target. In addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. If the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. The study aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy. The study is noninterventional and patients' standard treatment will not be affected by their participation in the study.
- Conditions
- Head and Neck Cancer
- Being tested
- MRI Scan, PET-CT Scan, No intervention
- 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 ScanProcedure or surgery
PET-CT ScanProcedure or surgery
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Routine radiotherapy treatment plus MRI scan and PET-CT scan | Other | Not described Receives: Procedure: MRI Scan; Procedure: PET-CT Scan |
| Routine radiotherapy treatment | Other | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of utilising MRI images in head and neck radiotherapy planning.
Determine whether MRI images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Measured: 40-60 minutes
Feasibility of utilising PET-CT images in head and neck radiotherapy planning.
Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
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
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273778
- Sponsor's protocol ID
- CO10/9645
- Other IDs
- 11/YH/0212
- Status last verified
- Aug 2019
- First submitted
- 14 Oct 2014
- Last updated
- 20 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Use of Co-registered 18FDG-PET-CT and MRI for Radiotherapy Planning in Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02273778
- Acronym / sponsor ID
- CO10/9645
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Oct 2014 (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.
Radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. In order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. At present a computerized tomography (CT) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. The investigators know that other types of scan including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans are better than CT scans at showing areas involved by the cancer. However, radiotherapy cannot be directly planned on these types of scans. The aim of this study is to explore whether PET and MRI scans can be combined with CT scans to more accurately identify the tumour target. In addition, this study will explore whether PETCT and MRI scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. If the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. The study aims to recruit 16 patients. All patients within the study will undergo a PETCT and an MRI scan prior to starting treatment as part of the study. A subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy. The study is noninterventional and patients' standard treatment will not be affected by their participation in the study.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine radiotherapy treatment plus MRI scan and PET-CT scan | Other | Procedure: MRI Scan, Procedure: PET-CT Scan |
| Routine radiotherapy treatment | Other | Other: No intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18
- WHO Performance status 02
- Histologically proven squamous cell carcinoma of the head and neck region
- Clinical decision made to proceed with a course of radiotherapy of curative intent of 6670Gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy
- Measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
Key exclusion criteria (11 listed)
- Hypersensitivity to fluorine-18 FDG
- Hypersensitivity to iodinated contrast media or Gadolinium
- Poorly controlled diabetes
- Acute renal failure or moderate renal impairment (estimated glomerularb filtration rate < 30 mL/min)
- Contraindication to MRI imaging, including cardiac pacemaker or presence of MRI incompatible metalwork
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 Scan | Procedure or surgery | Routine radiotherapy treatment plus MRI scan and PET-CT scan |
| PET-CT Scan | Procedure or surgery | Routine radiotherapy treatment plus MRI scan and PET-CT scan |
| No intervention | Other | Routine radiotherapy treatment |
Primary outcome
Feasibility of utilising MRI images in head and neck radiotherapy planning.
Time frame: 40-60 minutes
Determine whether MRI images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Feasibility of utilising PET-CT images in head and neck radiotherapy planning.
Time frame: 2 hours
Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
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 20 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan and PET-CT Scan in people with Head and Neck Cancer, run by The Leeds Teaching Hospitals NHS Trust.
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 8 inclusion and 11 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 20 Aug 2019. 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?
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?
Feasibility of utilising MRI images in head and neck radiotherapy planning. (time frame: 40-60 minutes). 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 20 Aug 2019.