Diagnostic and clinical value of HER2-PET/CT in patients with breast cancer and a clinical dilemma
- Conditions
- Metastatic breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003789-41-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 20
•Patients with a history of histological and/or cytological proven HER2-positive primary breast cancer. HER2-positivity is defined as:
i. HER2 immunohistochemical score of 3+, or
ii. HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2 amplification.
•Patients with suspected metastatic disease or local recurrence of HER2-positive breast cancer and a clinical dilemma:
i.in whom standard work up with imaging has failed to solve the clinical dilemma (diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions and
ii.in whom a biopsy is desirable but cannot (easily) be performed due to technical or patient factors or otherwise.
•Standard work-up with imaging is defined as CT chest and abdomen, bone
scintigraphy, as well as FDG-PET.
•Age >18 years of age.
•WHO performance status 0-2.
•Signed written informed consent.
•Able to comply with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1.Pregnant or lactating women.
2.Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
3.Inability to comply with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method