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

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02273778

Collaborator

(none)

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Procedure: MRI Scan Procedure: PET-CT Scan Other: No intervention	N/A

Study Design

Study Type:

Interventional

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 Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Feasibility of utilising MRI images in head and neck radiotherapy planning. [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. [2 hours]
Determine whether PET-CT images in head and neck radiotherapy can be used to modify the tumour target volume during radiotherapy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Leeds Teaching Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT02273778

Other Study ID Numbers:

CO10/9645
11/YH/0212

First Posted:

Oct 24, 2014

Last Update Posted:

Aug 20, 2019

Last Verified:

Aug 1, 2019

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Aug 20, 2019