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RecruitingNCT04612075EMINENCEUpdated Apr 14, 2026

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

An observational study in Head and Neck Neoplasms, sponsored by Norwegian University of Science and Technology. Recruiting at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Norwegian University of Science and Technology · Observational

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
390
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Neoplasms

Keywords

  • Diagnostic Imaging
  • Functional Imaging
  • Nuclear magnetic Resonance Imaging
  • Positron-Emission Tomography
  • Radiotherapy
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 390 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
390 participants (estimated)
Patient registry
No

Groups and cohorts

  • All patients referred to fast track clinical pathway for HNC cancer

    MRI as part of staging, including a 5-minute additional sequence.

  • Patients with locally advanced HNC

    FDG-PET/MRI

    Diagnostic Test: FDG-PET/MRI

Interventions

  • Diagnostic testFDG-PET/MRI

    Performed at baseline, interim and at 12-16 weeks post radiotherapy.

06

What researchers measure

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 treatment

  2. 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 treatment

Secondary outcomes

  1. Populations 1 and 2: Time to local relapse and time to distant metastasis

    Time frame: Five years after treatment

07

Study locations

1 of 2 sites recruiting
  • University Hospital of North Norway
    Tromsø, Norway
    Not yet recruiting
  • St Olavs Hospital, Department of Oncology
    Trondheim, Norway
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04612075
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, University Hospital of North Norway, University of Bergen
Responsible party
Sponsor
First posted
Nov 2, 2020
Start date
Jan 12, 2021
Primary completion
Dec 31, 2025
Completion
Dec 2028 (estimated)
Last update
Apr 14, 2026

Study contacts

Miriam Alsaker, phd
Contact
mirjam.alsaker@ntnu.no
+47 73598709
Kathrine Røe Redalen, phd
Contact
kathrine.redalen@ntnu.no
+47 92437646
Torstein Baade Rø, md phd
study director · Norwegian University of Science and Technology, IKOM
Arne Solberg, md phd
study director · St Olavs Hospital, Dept Oncology
Erik Wahlström, phd
study director · Norwegian University of Science and Technology, Institute for Fysikk

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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