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NCT03374826 | RECRUITING | Breast Cancer

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

Maastricht University Medical Center

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.

Condition or disease

Breast Cancer

Breast Neoplasms

Breast Diseases

Intervention/treatment

Dedicated axillary hybrid PET-MRI

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 125 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
Actual Study Start Date : 2018-02-22
Estimated Primary Completion Date : 2023-12
Estimated Study Completion Date : 2023-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients

Location Details

NCT03374826

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Netherlands,

Maastricht University Medical Center

Maastricht, Netherlands,

RECRUITING

Netherlands,

Erasmus Medical Center

Rotterdam, Netherlands, 3015GD