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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014