MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI Scan
PET-CT Scan
No intervention
Sponsored by
About this trial
This is an interventional trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Uncontrolled pain
- Urinary incontinence
- Female patients must not be pregnant and if of child bearing age using adequate contraception
- Breast feeding
- Serious psychiatric comorbidity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Routine radiotherapy treatment plus MRI scan and PET-CT scan
Routine radiotherapy treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02273778
First Posted
October 14, 2014
Last Updated
August 16, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02273778
Brief Title
MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Routine radiotherapy treatment plus MRI scan and PET-CT scan
Arm Type
Other
Arm Title
Routine radiotherapy treatment
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MRI Scan
Intervention Type
Procedure
Intervention Name(s)
PET-CT Scan
Intervention Type
Other
Intervention Name(s)
No intervention
Primary Outcome Measure Information:
Title
Feasibility of utilising MRI images in head and neck radiotherapy planning.
Description
Determine whether MRI images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Time Frame
40-60 minutes
Title
Feasibility of utilising PET-CT images in head and neck radiotherapy planning.
Description
Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Uncontrolled pain
Urinary incontinence
Female patients must not be pregnant and if of child bearing age using adequate contraception
Breast feeding
Serious psychiatric comorbidity
12. IPD Sharing Statement
Learn more about this trial
MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer
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