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Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) (HX-4)

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ClinicalTrials.gov Identifier: NCT00690053
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : June 30, 2009
Sponsor:
Collaborator:
VU University Medical Center
Information provided by:
Maastricht Radiation Oncology

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date June 30, 2009
Study Start Date  ICMJE August 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Toxicity (CTCAE 3.0) [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00690053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan) [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)
Official Title  ICMJE Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study
Brief Summary Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.
Detailed Description

To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients in two dose-steps:

  • Step 1 (3-6 patients): a single dose of maximum 6 mCi (222 MBq) dose of [18F]HX4 (which contains a maximum of 15 μg HX-4) via a bolus IV injection.
  • Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of [18F]HX4 (which contains a maximum of 27 μg HX-4) via a bolus IV injection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer
Intervention  ICMJE Procedure: Injection of HX-4
In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)
Study Arms  ICMJE Experimental: 1
Intervention: Procedure: Injection of HX-4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
  • Normal white blood cell count and neutrophils
  • Normal platelet count
  • No anaemia requiring blood transfusion or erythropoietin
  • Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
  • Calculated Creatinin clearance at least 60 ml/min
  • No administration of Fluor-18 in the previous 24 hours
  • Capable of complying with study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690053
Other Study ID Numbers  ICMJE 08-3-040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dr. D.K.M. De Ruysscher, Maastro Clinic
Study Sponsor  ICMJE Maastricht Radiation Oncology
Collaborators  ICMJE VU University Medical Center
Investigators  ICMJE Not Provided
PRS Account Maastricht Radiation Oncology
Verification Date February 2009

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