To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer patients.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Toxicity (CTCAE 3.0)
Secondary outcome
1. Image Quality at different time points (Tumour-to-Background Ratio
determined by PET-CT scan)
2. Correlation of [18F]-HX4 on PET scans with circulating biomarkers of
hypoxia.
3. Correlation of [18F]-HX4 on PET scans with [18F]-FDG on PET scans
Background 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.
Study objective
To determine the toxicity of the hypoxia PET-tracer [18F]-HX4 in cancer
patients.
Study design
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
Study burden and risks
Injection of [18F]HX-4 via a bolus IV-injection, a dynamic PET-CT scan and 3
static scans. No toxicity is expected of [18F]HX-4.
The risk of radiation exposure is no more than a standard FGD-PET scan with
18F-Fluorodeoxyglucose (FDG), due to the short half life of 18F (110 min).
Dr Tanslaan 12
6229 ET Maastricht
Nederland
Dr Tanslaan 12
6229 ET Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
- WHO performance status 0 to 1
- Normal white blood cell count and formula
- Normal platelet count
- No anaemia requiring blood transfusion or erythropoietin
- Adequate hepatic function.
- Calculated Creatinin clearance at least 60 ml/min
- No administration of Fluor-18 in the previous 24 hours
- The patient is capable of complying with study procedures
- 18 years or older
Exclusion criteria
- Recent (< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- pregnant by testing patient with a serum or urine test within 24 hours of receiving 18F-Hx4
- No concurrent anti-cancer agents or radiotherapy allowed.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000828-92-NL |
| ClinicalTrials.gov | NCT00690053 |
| CCMO | NL22686.068.08 |