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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Procedure: Injection of HX-4

• Registration Number: NCT00690053
• Lead Sponsor: Maastricht Radiation Oncology

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 Timeline

• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Study Start: 2008-08
• Status Verified: 2009-02
• Primary Completion: 2009-02
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Injection of HX-4	-

Primary Outcome Measures

Name	Time	Method
Toxicity (CTCAE 3.0)	9 months

Secondary Outcome Measures

Name	Time	Method
Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)	9 months

Trial Locations

Locations (1)

Maastricht Radiation Oncology (MAASTRO clinic); 🇳🇱 Maastricht, Netherlands