The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
ConditionHead and Neck Neoplasms
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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FDG-PET/MRI
Diagnostic testPerformed at baseline, interim and at 12-16 weeks post radiotherapy.
Treatment groups
390 Participants
are divided into 2 treatment groupsGroup A: All patients referred to fast track clinical pathway for HNC cancer0 interventions
Group B: Patients with locally advanced HNC1 intervention
Trial outcomes
Primary outcomes
1
Population 1: Predict overall survival 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.
Time frame
Five years after treatment2
Population 2: Response three months after treatment
For study population two, the primary objective is response three months after treatment.
Time frame
Three months after treatmentSecondary outcomes
1
Populations 1 and 2: Time to local relapse and time to distant metastasis
Time frame
Five years after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
St. Olavs Hospital
Collaborator
University Hospital of North Norway
Collaborator
University of Bergen
Collaborator
Source ClinicalTrials.gov