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NCT Number: NCT04612075

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

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.

Recruiting

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Norway, Tromsø, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG-PET/MRI

Diagnostic Test

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

Primary outcomes

  1. Population 1: Predict overall survival five years after treatment

    Time frame: 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.

  2. Population 2: Response three months after treatment

    Time frame: Three months after treatment

    For study population two, the primary objective is response 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrine Røe Redalen, phd

CONTACT

[email protected]

+47 92437646

Miriam Alsaker, phd

CONTACT

[email protected]

+47 73598709

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital
  • University Hospital of North Norway
  • University of Bergen

Registry information

Acronym: EMINENCE

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Nov 2, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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