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

This study is currently recruiting participants.
Verified September 2013 by Maastricht Radiation Oncology
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01347281
First received: May 3, 2011
Last updated: September 20, 2013
Last verified: September 2013

May 3, 2011
September 20, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
Visualisation of tumor hypoxia with [18F] HX4 PET imaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Proportion hypoxic head and neck tumors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion hypoxic head and neck tumors
Complete list of historical versions of study NCT01347281 on ClinicalTrials.gov Archive Site
  • Observe spatial and temporal stability of [18F] HX4 PET images [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of [18F] HX4 with local tumor recurrence and survivalG PET [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Image quality of [18F] HX4-PET at different time points [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Kinetic analysis of HX4 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of hypoxia imaging with blood hypoxia markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation of hypoxia imaging with tumor tissue biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Stability of [18F] HX4 PET images and its correlation with tumor markers and FDG PET [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Observe spatial and temporal stability of [18F] HX4 PET images
  • Correlation of [18F] HX4 with local tumor recurrence and survival
  • Image quality of [18F] HX4-PET at different time points
  • Kinetic analysis of HX4
  • Correlation of hypoxia imaging with blood hypoxia markers
  • Correlation of hypoxia imaging with tumor tissue biomarkers
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Not Provided
Not Provided
 
PET With [18F]HX4 in Head and Neck Cancer
Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cancer of the Head and Neck
Procedure: 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

Other Name: 3-[18F]fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1-yl)propan-1-ol
Experimental: [18F]HX4 PET
Injection of [18F]HX4 and imaging at baseline and after 20 Gy radiation therapy
Intervention: Procedure: Injection of [18F]HX4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frank Hoebers, Dr. 31-88-445-5666 Frank.Hoebers@maastro.nl
Netherlands
 
NCT01347281
11-12-23/03-intern-6470, 2011-001812-80
Yes
Maastricht Radiation Oncology
Maastricht Radiation Oncology
Not Provided
Not Provided
Maastricht Radiation Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP