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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04612075
• Collaborator: St. Olavs Hospital (Other), University Hospital of North Norway (Other), University of Bergen (Other)
• Enrollment: 390
• Locations: 2
• Anticipated Duration (Months): 94.6
• Patients Per Site: 195
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms	Diagnostic Test: FDG-PET/MRI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 390 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
• Actual Study Start Date: Jan 12, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Population 1: Predict overall survival five years after treatment [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 [Three months after treatment]

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

Secondary Outcome Measures

1. Populations 1 and 2: Time to local relapse and time to distant metastasis [Five years after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of North Norway	Tromsø		Norway
2	St Olavs Hospital, Department of Oncology	Trondheim		Norway

Sponsors and Collaborators

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

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT04612075
• Other Study ID Numbers: 64744
• First Posted: Nov 2, 2020
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Diagnostic Imaging; Functional Imaging; Nuclear magnetic Resonance Imaging; Positron-Emission Tomography; Radiotherapy
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Jan 20, 2022