PET-MRI for Axillary Staging in Node Negative Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03374826|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : March 7, 2019
|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)|
|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|
|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.
- 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.
- 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.
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
|Maastricht University Medical Center||Recruiting|
|Contact: Sanaz Samiei, MD 0433881575 email@example.com|
|Principal Investigator: Marjolein Smidt, MD, PhD|