Clinical trial · Interventional
Measurement of Head and Neck Tumor Hypoxia With PET-MRI
Simultaneous PET-MRI for Comparison of Advanced DW-MRI Techniques and EF5-PET in the Detection of Hypoxia in Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using \[18F\]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET-MRI
- description
- Simultaneous 18F-EF5 PET and DW-MRI
- interventionNames
- Diagnostic Test: PET-MRI
Primary outcomes (1)
- measure
- PET-MRI correlation
- timeFrame
- 1 day
- description
- Voxel level correlation of DW-MRI and PET estimates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 80 years old * Sex: male or female * Language spoken: Finnish or Swedish * Performance status: Karnofsky score 70 or better or WHO performance status 2 or better * Mental status: Patients must be able to understand the meaning of the study * Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck (oral cavity, pharynx or larynx) * Primary tumor diameter as determined clinically or from contrast enhanced CT or MRI scan must be at least 20 mm * Patients with nodal neck metastases of head and neck cancer are eligible * Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff * Gravidity: Patient, if female, must not be pregnant or lactating at the time of the study Exclusion Criteria: * Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia) * Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators. * Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer * Infections: Patient must not have an uncontrolled serious infection * Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.
References
Publications (0)
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