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

This study is currently recruiting participants.
Verified July 2012 by Maastricht Radiation Oncology
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01347281
First received: May 3, 2011
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Cancer of the Head and Neck
 Procedure: Injection of [18F]HX4
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]HX4 PET
Injection of [18F]HX4 and imaging at baseline and after 20 Gy radiation therapy
 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: 30-40 min dynamic and static scans t 90 min, 180 min and 240 min p.i.

Venous blood sampling: before injection of [18F]HX4 (blood hypoxia markers) and after dynamic acquisition (radio-activity in blood)

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347281

Contacts
Contact: Frank Hoebers, Dr. 31-88-445-5666 Frank.Hoebers@maastro.nl

Locations
Netherlands
Maastricht Radiation Oncology (MAASTRO clinic) Recruiting
Maastricht, Netherlands, 6229 ET
Sub-Investigator: Frank Hoebers, dr            
Principal Investigator: Philippe Lambin, Prof            
Sponsors and Collaborators
Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01347281     History of Changes
Other Study ID Numbers: 11-12-23/03-intern-6470, 2011-001812-80
Study First Received: May 3, 2011
Last Updated: July 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Cancer of the Head and Neck
[18F]HX4
hypoxia
PET
phase II trial

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

ClinicalTrials.gov processed this record on May 23, 2013