The EMINENCE Study - PET/MR Imaging of Head Neck Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FDG-PET/MRI

Treatment groups

390 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Norwegian University of Science and Technology

Lead sponsor

St. Olavs Hospital

Collaborator

University Hospital of North Norway

Collaborator

University of Bergen

Collaborator