Status:
RECRUITING
Measurement of Head and Neck Tumor Hypoxia With PET-MRI
Lead Sponsor:
Turku University Hospital
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a non-randomized prospective study which aims to compare \[18F\]EF5 PET data and MR imaging data acquired with simultaneous PET/MR imaging. Hypoxic tumor tends to be more aggressive than its n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05246475
Start Date
February 8 2022
End Date
October 1 2026
Last Update
February 18 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Turku University Hospital
Turku, G102881, Finland, 20521