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

NCT04612075 | Recruiting

• 1 other identifier: 64744
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms

Keywords

Diagnostic Imaging; Functional Imaging; Nuclear magnetic Resonance Imaging; Positron-Emission Tomography; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Five years after treatment

• Population 2: Response three months after treatment

  For study population two, the primary objective is response three months after treatment.

  Three months after treatment

Secondary Outcomes (1)

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

  Five years after treatment

Study Arms (2)

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

FDG-PET/MRI DIAGNOSTIC_TEST

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

Patients with locally advanced HNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• University of Bergen: collaborator

Study Sites (2)

University Hospital of North Norway

Tromsø, Norway

NOT YET RECRUITING

St Olavs Hospital, Department of Oncology

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Torstein Baade Rø, md phd

  Norwegian University of Science and Technology, IKOM

  STUDY DIRECTOR

• Arne Solberg, md phd

  St Olavs Hospital, Dept Oncology

  STUDY DIRECTOR

• Erik Wahlström, phd

  Norwegian University of Science and Technology, Institute for Fysikk

  STUDY DIRECTOR

Central Study Contacts

Miriam Alsaker, phd

CONTACT

+47 73598709; mirjam.alsaker@ntnu.no

Kathrine Røe Redalen, phd

CONTACT

+47 92437646; kathrine.redalen@ntnu.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: January 12, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

NO (2)