on invasive imaging of [18F] HX-4 with Positron-Emission-Tomography (PET): A phase I trial

Completed

Conditions: stage IV cancer
10027656

Registration Number: NL-OMON31922

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Toxicity (CTCAE 3.0) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Image Quality at different time points (Tumour-to-Background Ratio<br /><br>determined by PET-CT scan)<br /><br>2. Correlation of [18F]-HX4 on PET scans with circulating biomarkers of<br /><br>hypoxia.<br /><br>3. Correlation of [18F]-HX4 on PET scans with [18F]-FDG on PET scans</p><br>