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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Maastricht University Medical Center
RECRUITING
Maastricht
Erasmus Medical Center
RECRUITING
Rotterdam
Time Frame
Start Date: 2018-02-22
Estimated Completion Date: 2023-12
Participants
Target number of participants: 125
Treatments
Experimental: Dedicated axillary hybrid PET-MRI axilla
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Erasmus Medical Center

This content was sourced from clinicaltrials.gov