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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03374826
• Other study ID #: NL62441.068.17
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Secondary	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.	Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks