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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01347281
First received: May 3, 2011
Last updated: January 27, 2017
Last verified: January 2017
May 3, 2011
January 27, 2017
December 2011
August 2015   (Final data collection date for primary outcome measure)
Visualisation of tumor hypoxia with [18F] HX4 PET imaging [ Time Frame: 2 years ]
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Proportion hypoxic head and neck tumors [ Time Frame: 2 years ]
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 ]
  • Correlation of [18F] HX4 with local tumor recurrence and survivalG PET [ Time Frame: 2 years ]
  • Image quality of [18F] HX4-PET at different time points [ Time Frame: 2 years ]
  • Kinetic analysis of HX4 [ Time Frame: 2 years ]
  • Correlation of hypoxia imaging with blood hypoxia markers [ Time Frame: 2 years ]
  • Correlation of hypoxia imaging with tumor tissue biomarkers [ Time Frame: 2 years ]
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment [ Time Frame: 2 years ]
  • Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment [ Time Frame: 2 years ]
Stability of [18F] HX4 PET images and its correlation with tumor markers and FDG PET [ Time Frame: 2 years ]
  • 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
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Cancer of the Head and Neck
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

Experimental: [18F]HX4 PET
Injection of [18F]HX4
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.
 
Completed
23
September 2015
August 2015   (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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01347281
11-12-23/03-intern-6470
2011-001812-80 ( EudraCT Number )
Yes
Not Provided
Undecided
Not Provided
Maastricht Radiation Oncology
Maastricht Radiation Oncology
Not Provided
Principal Investigator: Philppe Lambin, Prof. Dr. Maastro Clinic, The Netherlands
Maastricht Radiation Oncology
January 2017

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