Clinical trial NCT04612075: The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
Official title: The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Neoplasms
Keywords: Diagnostic Imaging
Functional Imaging
Nuclear magnetic Resonance Imaging
Positron-Emission Tomography
Radiotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital of North Norway
name: University of Bergen
First posted: 2020-11-02
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population 1 consists of all patients who are referred to the "fast track" clinical pathway for HNC at St. Olavs hospital, approximately 130 patients per year for three years. Out of these, 60 patients are defined as study population 2, due to locally advanced head and neck cancer (HNC) of squamous cell histology scheduled for definitive (chemo)radiotherapy with curative intent.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Population 1: Predict overall survival five years after treatment
timeFrame: Five years after treatment
measure: Population 2: Response three months after treatment
timeFrame: Three months after treatment
Secondary outcomes:
measure: Populations 1 and 2: Time to local relapse and time to distant metastasis
timeFrame: Five years after treatment
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital, Department of Oncology
Study officials:
affiliation: Norwegian University of Science and Technology, IKOM
name: Torstein Baade Rø, md phd
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Dept Oncology
name: Arne Solberg, md phd
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Institute for Fysikk
name: Erik Wahlström, phd
role: STUDY_DIRECTOR
References: