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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690053

Acronym

HX-4

Enrollment

Registered

2008-06-04

Start date

2008-08-31

Completion date

Unknown

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Toxicity, PET, HX-4, cancer

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.

Interventions

PROCEDUREInjection 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Toxicity (CTCAE 3.0)	9 months

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026