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

Head and Neck Neoplasms Clinical Trial

— EMINENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612075
• Other study ID #: 64744
• Status: Recruiting
• Start date: January 12, 2021
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Norwegian University of Science and Technology
• Contact: Miriam Alsaker, phd
• Phone: +47 73598709
• Email: mirjam.alsaker[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Diagnostic Test:
• FDG-PET/MRI
Performed at baseline, interim and at 12-16 weeks post radiotherapy.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø
Norway	St Olavs Hospital, Department of Oncology	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital, University Hospital of North Norway, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Populations 1 and 2: Time to local relapse and time to distant metastasis		Five years after treatment