on invasive imaging of Cetuximab-Zirconium-89 uptake with Positron-Emission-Tomography (PET) scans: A phase I trial in stage IV cancer patients.

Completed

• Conditions: stage IV cancer; 10038666

• Registration Number: NL-OMON35426
• Lead Sponsor: MAASTRO clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Histological or cytological confirmed stage IV cancer
- Primary or recurrent stage IV (UICC 2002; sixth edition)
- WHO Performance 0-2
- Measurable cancer on PET-scan, i.e. index lesion with a volume of at least 6cm3
- No recent severe cardiac disease
- Adequate bone marrow
- Adequate renal function
- Adequate hepatic function
- Life expectancy > 3 months
- Willing and able to comply with study prescriptions
- 18 years or older
- Not pregant or breast feading
- Written informed consent
- No previous administration of Cetuximab

Exclusion Criteria

- Mixed pathology (non-small cell lung cancer plus small cell lung cancer)
- Recent myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- Other active malignancy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MTD (Maximum Tolereerbare Dosis) Zirconium-89 labelled Cetuximab in patients<br /><br>with stage IV cancer</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Toxicity (CTCAE 3.0)<br /><br>Optimalisation of tumour visualization</p><br>