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

Cancer of the Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347281
• Other study ID #: 11-12-23/03-intern-6470
• Secondary ID: 2011-001812-80
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: January 27, 2017
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht Radiation Oncology (MAASTRO clinic)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Country where clinical trial is conducted

Netherlands, 

Outcome

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