Status:
UNKNOWN
PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with ti...
Eligibility Criteria
Inclusion
- Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
- Patients who are willing and able to undergo the study procedures
- The patient has provided personally written informed consent
Exclusion
- Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
- Patients with clinically positive axillary lymph nodes
- Age \< 18 years
- Inability to provide informed consent
- Pregnancy
- Weight \>100 kg (because of the format of the PET/MRI scanner)
- General contraindications for MRI (such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia) or PET (i.e. known allergy to 18F-FDG)
- Hyperglycaemia (\> 11 mmol/L) at the time of 18F-FDG injection
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03374826
Start Date
February 22 2018
End Date
December 1 2023
Last Update
October 31 2023
Active Locations (2)
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1
Maastricht University Medical Center
Maastricht, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands, 3015GD