HER Image: 89Zr-DFO* trastuzumab PET in patients with breast cancer - a pilot study
- Conditions
- Mammary carcinomabreast cancer.10027476
- Registration Number
- NL-OMON55969
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
Patients with:
- HER2+ or HER2-low breast cancer with metastatic disease,
- and starting systemic therapy or having stable, RECIST measurable disease
(with or without treatment).
• A recent (< 16 weeks of start of study) biopsy confirming HER2-status, as
long as no therapy changes took place within those 16 weeks.
• Able to undergo PET imaging procedures.
• At least one lesion of at least 1.5 cm amenable for PET imaging
• Age >18 years of age, willing and able to comply with the protocol as judged
by the investigator.
• Signed written informed consent.
• Have a World Health Organisation (WHO) performance status of 0-2.
• Life expectancy of > 3 months.
• Have measurable disease based on RECIST 1.1.
• Adequate organ and bone marrow function, as deemed acceptable by the treating
physician
• Contraindications for systemic treatment (as will be assigned by treating
physician).
• Pregnant or lactating women.
• Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
• Inability to comply with study procedures.
• Has substance abuse or any other medical conditions such as clinically
significant cardiac or psychological conditions, that may, in the opinion of
the investigator, interfere with the subject*s participation in the clinical
study or evaluation of the clinical study results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method