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

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Dec 11, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to check the lymph nodes in patients with breast cancer to see if the cancer has spread. Currently, if doctors find no signs of cancer in the lymph nodes, patients usually undergo a procedure called sentinel lymph node biopsy (SLNB), which involves surgery. This trial aims to see if a special imaging technique called hybrid PET/MRI can accurately determine if the lymph nodes are free of cancer without needing surgery. If this method works well, it could make the process easier and reduce the need for surgery in some patients.

To participate in this trial, you must be a female patient diagnosed with breast cancer who has been confirmed to have no suspicious lymph nodes. You should also be willing to undergo the study procedures and provide consent. The trial is open to women aged 65 to 74. Those with certain conditions, such as prior treatment for breast cancer or positive lymph nodes, won't be eligible. If you join the trial, you can expect to undergo the hybrid PET/MRI imaging, and researchers will compare the results to the standard surgical method to see how well they match. This could lead to less invasive options for patients in the future.

Gender

FEMALE

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