RecruitingNot ApplicableNCT05246475
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
Sponsor
Turku University Hospital
Enrollment
30 participants
Start Date
Feb 8, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria10
- 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 Criteria5
- 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.
Interventions
DIAGNOSTIC_TESTPET-MRI
Simultaneous PET-MRI measurement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05246475
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