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

NCT03374826 | Unknown DMC

• 1 other identifier: NL62441.068.17
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Dedicated axillary hybrid PET-MRI axilla

EXPERIMENTAL

Diagnostic Test: Dedicated axillary hybrid PET-MRI

Interventions

Dedicated axillary hybrid PET-MRI DIAGNOSTIC_TEST

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

Dedicated axillary hybrid PET-MRI axilla

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 15, 2017
• Study Start: February 22, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)