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

NCT ID: NCT04612075

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 390 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-12
• Study Completion Date: 2028-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients referred to fast track clinical pathway for HNC cancer

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

No interventions assigned to this group

Patients with locally advanced HNC

FDG-PET/MRI

FDG-PET/MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

FDG-PET/MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torstein Baade Rø, md phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, IKOM

Arne Solberg, md phd

Role: STUDY_DIRECTOR

St Olavs Hospital, Dept Oncology

Erik Wahlström, phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Institute for Fysikk

Locations

University Hospital of North Norway

Tromsø, , Norway

Site Status: NOT_YET_RECRUITING

St Olavs Hospital, Department of Oncology

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Miriam Alsaker, phd

Role: CONTACT

mirjam.alsaker@ntnu.no

+47 73598709

Kathrine Røe Redalen, phd

Role: CONTACT

kathrine.redalen@ntnu.no

+47 92437646

Facility Contacts

Mirjam Alsaker, md phd

Role: primary

mirjam.alsaker@ntnu.no

Other Identifiers

64744

Identifier Type: -

Identifier Source: org_study_id