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Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.

Phase 2
18 Years
Open (Enrolling)
Cancer of the Head and Neck

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Trial Information

Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visualisation of tumor hypoxia with [18F] HX4 PET imaging

Outcome Description:

Visualisation of tumor hypoxia with [18F] HX4 PET imaging

Outcome Time Frame:

2 years

Safety Issue:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

December 2011

Completion Date:

December 2013

Related Keywords:

  • Cancer of the Head and Neck
  • Cancer of the Head and Neck
  • [18F]HX4
  • hypoxia
  • PET
  • phase II trial
  • Head and Neck Neoplasms