NCT02273778

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

October 14, 2014

Last Update Submit

August 16, 2019

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 hours

Study Arms (2)

Routine radiotherapy treatment plus MRI scan and PET-CT scan

OTHER
Procedure: MRI ScanProcedure: PET-CT Scan

Routine radiotherapy treatment

OTHER
Other: No intervention

Interventions

MRI ScanPROCEDURE
Routine radiotherapy treatment plus MRI scan and PET-CT scan
PET-CT ScanPROCEDURE
Routine radiotherapy treatment plus MRI scan and PET-CT scan
No interventionOTHER
Routine radiotherapy treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 24, 2014

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 20, 2019

Record last verified: 2019-08