PET With [18F]HX4 in Head and Neck Cancer

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT01347281

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the Head and Neck	Procedure: Injection of [18F]HX4	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [18F]HX4 PET Injection of [18F]HX4	Procedure: Injection of [18F]HX4 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

Arm

Intervention/Treatment

Experimental: [18F]HX4 PET

Injection of [18F]HX4

Procedure: Injection of [18F]HX4

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

Outcome Measures

Primary Outcome Measures

Visualisation of tumor hypoxia with [18F] HX4 PET imaging [2 years]
Visualisation of tumor hypoxia with [18F] HX4 PET imaging

Secondary Outcome Measures

Observe spatial and temporal stability of [18F] HX4 PET images [2 years]
Correlation of [18F] HX4 with local tumor recurrence and survivalG PET [2 years]
Image quality of [18F] HX4-PET at different time points [2 years]
Kinetic analysis of HX4 [2 years]
Correlation of hypoxia imaging with blood hypoxia markers [2 years]
Correlation of hypoxia imaging with tumor tissue biomarkers [2 years]
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment [2 years]
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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