NCT04612075 The EMINENCE Study - PET/MR Imaging of Head Neck Cancer
| NCT ID | NCT04612075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian University of Science and Technology |
| Condition | Head and Neck Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 390 participants |
| Start Date | 2021-01-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 390 participants in total. It began in 2021-01-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Torstein Baade Rø, md phd
STUDY DIRECTOR
Norwegian University of Science and Technology, IKOM
Frequently Asked Questions
Who can join the NCT04612075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04612075 currently recruiting?
Yes, NCT04612075 is actively recruiting participants. Contact the research team at mirjam.alsaker@ntnu.no for enrollment information.
Where is the NCT04612075 trial being conducted?
This trial is being conducted at Tromsø, Norway, Trondheim, Norway.
Who is sponsoring the NCT04612075 clinical trial?
NCT04612075 is sponsored by Norwegian University of Science and Technology. The principal investigator is Torstein Baade Rø, md phd at Norwegian University of Science and Technology, IKOM. The trial plans to enroll 390 participants.