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

NCT ID: NCT03374826

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2023-12-31

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dedicated axillary hybrid PET-MRI axilla

Group Type: EXPERIMENTAL

Dedicated axillary hybrid PET-MRI

Intervention Type: DIAGNOSTIC_TEST

All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.

Interventions

Dedicated axillary hybrid PET-MRI

All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status: RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Kees de Mooij, MD

Role: primary

c.demooij@maastrichtuniversity.nl

+31 43 388 5054

Cécile de Monyé, MD, PhD

Role: primary

c.demonye@erasmusmc.nl

0031-7040265

Other Identifiers

NL62441.068.17

Identifier Type: -

Identifier Source: org_study_id