Measurement of Head and Neck Tumor Hypoxia With PET-MRI

Recruiting now · Not applicable

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT05246475

Run by

Turku University Hospital

People needed

30

Starts

2022-02-08

Expected to finish

2026-10-01

Last updated by the study team

2022-02-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Turku University Hospital — Turku, G102881, Finland (enrolling)

Full record on ClinicalTrials.gov

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