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

This study has been completed.
Sponsor:
Collaborator:
VU University Medical Center
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00690053
First received: June 2, 2008
Last updated: June 29, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Cancer
Procedure: Injection of HX-4
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Toxicity (CTCAE 3.0) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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)

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.
  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690053

Locations
Netherlands
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
VU University Medical Center
  More Information

No publications provided

Responsible Party: dr. D.K.M. De Ruysscher, Maastro Clinic
ClinicalTrials.gov Identifier: NCT00690053     History of Changes
Other Study ID Numbers: 08-3-040
Study First Received: June 2, 2008
Last Updated: June 29, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Toxicity
PET
HX-4
cancer

ClinicalTrials.gov processed this record on April 17, 2014