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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Neoplasms; Breast Diseases
• Interventions: Diagnostic Test: Dedicated axillary hybrid PET-MRI

• Registration Number: NCT03374826
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Study Start: 2018-02-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dedicated axillary hybrid PET-MRI axilla	Dedicated axillary hybrid PET-MRI	-

Primary Outcome Measures

Name	Time	Method
Accuracy of dedicated hybrid PET/MRI	Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of T2w MRI, DWI and Hybrid PET/MRI	Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks	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.

Trial Locations

Locations (2)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands