An interventional study of Dedicated axillary hybrid PET-MRI in Breast Cancer, Breast Neoplasms and Breast Diseases, sponsored by Maastricht University Medical Center. Recruiting at 2 sites in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
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.
Accuracy of dedicated hybrid PET/MRI
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI to exclude axillary lymph node metastases will be calculated.
Time frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Accuracy of T2w MRI, DWI and Hybrid PET/MRI
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of three MRI sequences (T2w, DWI and hybrid PET/MRI) to exclude axillary lymph node metastases will be calculated separately as well.
Time frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Plan to share: No
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Maastricht University Medical Center