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

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ClinicalTrials.gov Identifier: NCT03374826
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Breast Cancer Breast Neoplasms Breast Diseases Diagnostic Test: Dedicated axillary hybrid PET-MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dedicated axillary hybrid PET-MRI axilla Diagnostic Test: Dedicated axillary hybrid PET-MRI
All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.




Primary Outcome Measures :
  1. Accuracy of dedicated hybrid PET/MRI [ Time Frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Accuracy of T2w MRI, DWI and Hybrid PET/MRI [ Time Frame: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks ]
    Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of three MRI sequences (T2w, DWI and hybrid PET/MRI) to exclude axillary lymph node metastases will be calculated separately as well.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374826


Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Sanaz Samiei, MD    0433881575    sanaz.samiei@mumc.nl   
Principal Investigator: Marjolein Smidt, MD, PhD         
Sponsors and Collaborators
Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03374826     History of Changes
Other Study ID Numbers: NL62441.068.17
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases