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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347281
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
Maastricht Radiation Oncology

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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 : December 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Visualisation of tumor hypoxia with [18F] HX4 PET imaging [ Time Frame: 2 years ]
    Visualisation of tumor hypoxia with [18F] HX4 PET imaging

Secondary Outcome Measures :
  1. Observe spatial and temporal stability of [18F] HX4 PET images [ Time Frame: 2 years ]
  2. Correlation of [18F] HX4 with local tumor recurrence and survivalG PET [ Time Frame: 2 years ]
  3. Image quality of [18F] HX4-PET at different time points [ Time Frame: 2 years ]
  4. Kinetic analysis of HX4 [ Time Frame: 2 years ]
  5. Correlation of hypoxia imaging with blood hypoxia markers [ Time Frame: 2 years ]
  6. Correlation of hypoxia imaging with tumor tissue biomarkers [ Time Frame: 2 years ]
  7. Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment [ Time Frame: 2 years ]
  8. Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347281

Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Principal Investigator: Philppe Lambin, Prof. Dr. Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology Identifier: NCT01347281     History of Changes
Other Study ID Numbers: 11-12-23/03-intern-6470
2011-001812-80 ( EudraCT Number )
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Maastricht Radiation Oncology:
Cancer of the Head and Neck
phase II trial

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site