Clinical trial NCT01347281: PET With [18F]HX4 in Head and Neck Cancer
Official title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Head and Neck
Keywords: Cancer of the Head and Neck
[18F]HX4
hypoxia
PET
phase II trial
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
* Tumor diameter ≥ 2,5 cm
* WHO performance status 0 to 2
* Scheduled for primary curative (concurrent chemo-) radiotherapy
* No previous surgery to the head and neck
* No previous radiation to the head and neck
* Adequate renal function (calculated creatinine clearance at least 60 ml/min).
* The patient is willing and capable to comply with study procedures
* 18 years or older
* Have given written informed consent before patient registration

Exclusion Criteria:

* No recent (\< 3 months) myocardial infarction
* No Uncontrolled infectious disease
* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study

Primary outcomes:
measure: Visualisation of tumor hypoxia with [18F] HX4 PET imaging
timeFrame: 2 years
Secondary outcomes:
measure: Observe spatial and temporal stability of [18F] HX4 PET images
timeFrame: 2 years
measure: Correlation of [18F] HX4 with local tumor recurrence and survivalG PET
timeFrame: 2 years
measure: Image quality of [18F] HX4-PET at different time points
timeFrame: 2 years
measure: Kinetic analysis of HX4
timeFrame: 2 years
measure: Correlation of hypoxia imaging with blood hypoxia markers
timeFrame: 2 years
measure: Correlation of hypoxia imaging with tumor tissue biomarkers
timeFrame: 2 years
measure: Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
timeFrame: 2 years
measure: Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology (MAASTRO clinic)
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Philppe Lambin, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: