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

Recruiting

• Conditions: Head and Neck Neoplasms
• Interventions: Diagnostic Test: FDG-PET/MRI

• Registration Number: NCT04612075
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2021-01-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12-31
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with locally advanced HNC	FDG-PET/MRI	FDG-PET/MRI

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Populations 1 and 2: Time to local relapse and time to distant metastasis	Five years after treatment

Trial Locations

Locations (2)

St Olavs Hospital, Department of Oncology; 🇳🇴 Trondheim, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway