Using PET-MRI to assess lymph nodes in breast cancer patients
Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
This study is testing a new imaging method to see if it can accurately check lymph nodes in women with breast cancer, which might help avoid unnecessary surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 2 sites (Maastricht and 1 other locations) |
| Trial ID | NCT03374826 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of dedicated axillary hybrid PET-MRI imaging in determining the lymph node status of female patients with breast cancer who have clinically negative axillary lymph nodes. The goal is to potentially eliminate the need for invasive sentinel lymph node biopsy (SLNB) by accurately assessing lymph node involvement through non-invasive imaging techniques. If successful, this approach could reduce surgical complications and improve patient outcomes. The study will involve patients who are scheduled for SLNB and have provided informed consent.
Who should consider this trial
Good fit: Ideal candidates are female patients with histologically confirmed breast cancer and clinically negative lymph nodes in the axilla, who are scheduled to undergo SLNB.
Not a fit: Patients with clinically positive axillary lymph nodes or those who have received neoadjuvant systemic therapy prior to staging will not benefit from this study.
Why it matters
Potential benefit: If successful, this could reduce the need for invasive surgeries in breast cancer patients with negative lymph nodes, leading to fewer complications and better quality of life.
How similar studies have performed: While the use of PET and MRI in cancer imaging is established, this specific combination for axillary staging in breast cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maastricht and 1 other locations
- Maastricht University Medical Center — Maastricht, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.