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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study

Conditions
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Cancer

Intervention / Treatment
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* Procedure: Injection of HX-4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Injection of HX-4<br>* In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity (CTCAE 3.0) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan) |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxicity, PET, HX-4, cancer