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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
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All Sexes

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

    First Posted
    October 14, 2014
    Last Updated
    August 16, 2019
    Sponsor
    The Leeds Teaching Hospitals NHS Trust
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    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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