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CompletedNCT02273778Updated Aug 20, 2019

MRI and PET-CT for Radiotherapy Planning for Head and Neck Cancer

An interventional study of MRI Scan and PET-CT Scan in Head and Neck Cancer, sponsored by The Leeds Teaching Hospitals NHS Trust. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

Browse Head and Neck Neoplasms studies →

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 100 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable

Study arms

  • Other
    Routine radiotherapy treatment plus MRI scan and PET-CT scan

    Procedure: MRI Scan · Procedure: PET-CT Scan

  • Other
    Routine radiotherapy treatment

    Other: No intervention

Interventions

  • ProcedureMRI Scan
  • ProcedurePET-CT Scan
  • OtherNo intervention
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 40-60 minutes

  2. 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.

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2011, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2014
First posted
Oct 24, 2014
Start
Jun 2011
Primary completionActual
Jun 2013
CompletionActual
Jun 2013
Last update
Aug 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02273778
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Jun 2011
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Aug 20, 2019
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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