Clinical trial NCT03374826: PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients
Official title: Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Diseases
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2017-12-15
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 criteria: Inclusion Criteria:

1. Female patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
2. Patients who are willing and able to undergo the study procedures
3. The patient has provided personally written informed consent

Exclusion Criteria:

1. Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
2. Patients with clinically positive axillary lymph nodes
3. Age \< 18 years
4. Inability to provide informed consent
5. Pregnancy
6. Weight \>100 kg (because of the format of the PET/MRI scanner)
7. 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)
8. Hyperglycaemia (\> 11 mmol/L) at the time of 18F-FDG injection

Primary outcomes:
measure: Accuracy of dedicated hybrid PET/MRI
timeFrame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Secondary outcomes:
measure: Accuracy of T2w MRI, DWI and Hybrid PET/MRI
timeFrame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: