Head and Neck NeoplasmsEMINENCENCT04612075
The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
An observational study of Head and Neck Neoplasms, run by Norwegian University of Science and Technology at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- FDG-PET/MRI
- How many people
- 390 participants
- Where
- 2 sitesNorway
- Study dates
- 12 Jan 2021to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Not yet recruiting
University Hospital of North Norway
Tromsø
- Recruiting
St Olavs Hospital, Department of Oncology
Trondheim
Mirjam Alsaker, md phd, mirjam.alsaker@ntnu.no
About this study
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
- Being tested
- FDG-PET/MRI
- Keywords
- Diagnostic Imaging, Functional Imaging, Nuclear magnetic Resonance Imaging, Positron-Emission Tomography, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET/MRIDiagnostic test
Performed at baseline, interim and at 12-16 weeks post radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: FDG-PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five years after treatment
Population 2: Response three months after treatment
For study population two, the primary objective is response three months after treatment.
Measured: Three months after treatment
Secondary outcomes (1)
Populations 1 and 2: Time to local relapse and time to distant metastasis
Measured: Five years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start12 Jan 2021
- Primary completion31 Dec 2025
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Torstein Baade Rø, md phd, Study director, Norwegian University of Science and Technology, IKOMArne Solberg, md phd, Study director, St Olavs Hospital, Dept OncologyErik Wahlström, phd, Study director, Norwegian University of Science and Technology, Institute for Fysikk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612075
- Sponsor's protocol ID
- 64744
- Acronym
- EMINENCE
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
- ClinicalTrials.gov ID
- NCT04612075
- Acronym / sponsor ID
- EMINENCE / 64744
- Conditions
- Head and Neck Neoplasms
- Keywords
- Diagnostic Imaging, Functional Imaging, Nuclear magnetic Resonance Imaging, Positron-Emission Tomography, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway, University of Bergen
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: FDG-PET/MRIFDG-PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PET/MRIPerformed at baseline, interim and at 12-16 weeks post radiotherapy. | Diagnostic test | Patients with locally advanced HNC |
Primary outcome
Population 1: Predict overall survival five years after treatment
Time frame: 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
Time frame: Three months after treatment
For study population two, the primary objective is response three months after treatment.
1 secondary outcome
Populations 1 and 2: Time to local relapse and time to distant metastasis
Time frame: Five years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torstein Baade Rø, md phd study director
Norwegian University of Science and Technology, IKOM
Arne Solberg, md phd study director
St Olavs Hospital, Dept Oncology
Erik Wahlström, phd study director
Norwegian University of Science and Technology, Institute for Fysikk
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Alsaker, phd (+47 73598709, mirjam.alsaker@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population 1: Predict overall survival five years after treatment (time frame: Five years after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.