Head and Neck Neoplasms
Conditions
Keywords
Diagnostic Imaging, Functional Imaging, Nuclear magnetic Resonance Imaging, Positron-Emission Tomography, Radiotherapy
Brief summary
Head and neck cancers (HNC) often receive radiotherapy as part of their treatment. However, unacceptable failure rates and severe side effects remain a challenge. The improvements in radiotherapy are closely related to improvements in medical imaging. Functional imaging, where intratumoural characteristics such as tumour oxygenation, metabolism, and blood vessel function can be quantified, offers possibilities to personalize the radiotherapy. In this study we will establish the clinical workflow for PET- and MRI-based radiotherapy in HNC by acquiring images prior to and during radiotherapy to develop new concepts for image-based biologically adaptive radiotherapy, both based on photon-based radiotherapy and also proton therapy, which soon will be available for cancer patients in Norway. The investigators aim to contribute towards further developments of personalised high-precision radiotherapy for HNC patients resulting in improved outcome, reduced side-effects and better quality of life.
Interventions
DIAGNOSTIC_TESTFDG-PET/MRI
Performed at baseline, interim and at 12-16 weeks post radiotherapy.
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
University Hospital of North Norway
University of Bergen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee * histologically confirmed squamous cell carcinoma in the head neck region (pharynx, larynx, oral cavity or sinonasal area) * locally advanced disease without sign of dissemination (T3/T4 and/or N1-3, M0) on diagnostic imaging * scheduled for definitive radiotherapy with curative intent with or without concomitant chemotherapy * adequate renal function: Creatinine clearance ≥ 60 ml/minute * lymph node metastasis from cancer of unknown primary of the upper neck (i.e. level II-III) were PET/CT is negative outside the head-neck region can be considered for inclusion at the discretion of the study investigators.
Exclusion criteria
* general contraindications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) * serious comorbidity (including previous or othe cancer) that in the opinion of the investigator would compromise the patient's ability to complete the study of interfere with the evaluation of the study objectives (e.g. poorly controlled diabetes mellitus) * histologically confirmed SCC of same or other origin within the last five years * patient wants to withdraw for any reason during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Population 1: Predict overall survival five years after treatment | Five years after treatment | For study population one, the primary study objective is to explore the potential of functional MR imaging parameters in predicting overall survival in head and neck cancer (HNC) five years after treatment. |
| Population 2: Response three months after treatment | Three months after treatment | For study population two, the primary objective is response three months after treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Populations 1 and 2: Time to local relapse and time to distant metastasis | Five years after treatment |
Countries
Norway
Contacts
CONTACTMiriam Alsaker, phd
CONTACTKathrine Røe Redalen, phd
STUDY_DIRECTORTorstein Baade Rø, md phd
Norwegian University of Science and Technology, IKOM
STUDY_DIRECTORArne Solberg, md phd
St Olavs Hospital, Dept Oncology
STUDY_DIRECTORErik Wahlström, phd
Norwegian University of Science and Technology, Institute for Fysikk
Outcome results
None listed