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

NCT ID: NCT00690053

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

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.

Conditions

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Cancer

Keywords

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Toxicity PET HX-4 cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Injection of HX-4

Intervention Type PROCEDURE

In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)

Interventions

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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)

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

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Maastro Clinic

Locations

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Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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08-3-040

Identifier Type: -

Identifier Source: org_study_id