The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with \[18F\] HX4 PET imaging in head and neck tumors (ii) correlate the \[18F\] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of \[18F\] HX4 PET imaging (iv) compare \[18F\] HX4 PET uptake with \[18F\] FDG PET uptake before and after treatment.
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18F\]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, we expect that \[18F\]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18F\]-misonidazole. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies. Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N, M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). Before treatment a standard planning \[18F\]FDG PET-CT will be performed, a blood sample is drawn and baseline \[18F\]HX4 PET scans will be performed. 18F-HX4 scans will be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three months after the end of treatment a \[18F\]FDG PET scan will be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
Injection of \[18F\]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy: \[18F\]HX4 PET scans; 444 MBq (12 mCi) \[18F\]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i. Venous blood sampling: before injection of \[18F\]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): \[18F\]FDG PET in treatment position
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Visualisation of tumor hypoxia with \[18F\] HX4 PET imaging
Time frame: 2 years
Observe spatial and temporal stability of [18F] HX4 PET images
Time frame: 2 years
Correlation of [18F] HX4 with local tumor recurrence and survivalG PET
Time frame: 2 years
Image quality of [18F] HX4-PET at different time points
Time frame: 2 years
Kinetic analysis of HX4
Time frame: 2 years
Correlation of hypoxia imaging with blood hypoxia markers
Time frame: 2 years
Correlation of hypoxia imaging with tumor tissue biomarkers
Time frame: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Time frame: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Time frame: 2 years
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