NCT03374826

PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.

Conditions

• Breast Cancer
• Breast Neoplasms
• Breast Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dedicated axillary hybrid PET-MRI	All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.

Timeline

• Start date: 2018-02-22
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-12-15
• Last updated: 2023-10-31

Locations

2 sites across 1 country: Netherlands