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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Diagnostic test: FDG-PET/MRI

• Study Type: Observational
• Enrollment (Estimated): 390

Contacts and Locations

• Study Contact: Name: Miriam Alsaker, phd; Phone Number: +47 73598709; Email: mirjam.alsaker@ntnu.no
• Study Contact Backup: Name: Kathrine Røe Redalen, phd; Phone Number: +47 92437646; Email: kathrine.redalen@ntnu.no

Study Locations

• Norway
  • Tromsø, Norway
    • Not yet recruiting
    • University Hospital of North Norway
  • Trondheim, Norway
    • Recruiting
    • St Olavs Hospital, Department of Oncology
    • Contact: Mirjam Alsaker, md phd; Email: mirjam.alsaker@ntnu.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Performed at baseline, interim and at 12-16 weeks post radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Populations 1 and 2: Time to local relapse and time to distant metastasis	Five years after treatment

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: University Hospital of North Norway; University of Bergen; St. Olavs Hospital
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Positron-Emission Tomography; Diagnostic Imaging; Functional Imaging; Nuclear magnetic Resonance Imaging
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 64744

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No