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

Sponsors and Collaborators:	Maastricht Radiation Oncology VU University Medical Center
Information provided by:	Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:	NCT00690053

Purpose

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	Intervention	Phase
Cancer	Procedure: Injection of HX-4	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Non-Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PAT): A Phase I Study

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:

Toxicity (CTCAE 3.0) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	August 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690053

Contacts

Contact: Dirk De Ruysscher, Dr.

31-88-445-5666

dirk.deruysscher@maastro.nl

Locations

Netherlands
Maastricht Radiation Oncology (MAASTRO clinic)	Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Dirk De Ruysscher, Dr. 31-88-445-5666 dirk.deruysscher@maastro.nl
Principal Investigator: Dirk De Ruysscher, Dr.

Sponsors and Collaborators

Maastricht Radiation Oncology

VU University Medical Center

More Information

Responsible Party:	Maastro Clinic ( dr. D.K.M. De Ruysscher )
Study ID Numbers:	08-3-040
Study First Received:	June 2, 2008
Last Updated:	September 1, 2008
ClinicalTrials.gov Identifier:	NCT00690053
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:

Toxicity
PET
HX-4
cancer

ClinicalTrials.gov processed this record on January 15, 2009