HX-4: Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET)

Sponsor

Maastricht Radiation Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00690053

Collaborator

Amsterdam UMC, location VUmc (Other)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Procedure: Injection of HX-4	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Toxicity (CTCAE 3.0) [9 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht Radiation Oncology (MAASTRO clinic)	Maastricht		Netherlands	6229 ET

Sponsors and Collaborators

Maastricht Radiation Oncology
Amsterdam UMC, location VUmc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00690053

Other Study ID Numbers:

08-3-040

First Posted:

Jun 4, 2008

Last Update Posted:

Jun 30, 2009

Last Verified:

Feb 1, 2009

Keywords provided by , ,

Study Results

No Results Posted as of Jun 30, 2009