Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03510988|
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : April 27, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Newly Diagnosed Breast Cancer||Diagnostic Test: Hybrid breast FDG PET/MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
|Experimental: Women with newly diagnosed breast cancer||
Diagnostic Test: Hybrid breast FDG PET/MRI
Hybrid breast FDG PET/MRI
- Evaluate the specificity by adding breast FDG PET to MRI compared with breast MRI alone for the diagnosis on patients with newly diagnosed breast cancer [ Time Frame: 24 months ]
- Sensitivity, PPV, and NPV for the diagnosis based on the entire PET/MRI and MRI alone will be calculated and reported along with the corresponding two-sided 90% confidence intervals constructed by Wilson score method. [ Time Frame: 24 months ]Sensitivity, PPV, and NPV for the diagnosis based on the entire PET/MRI and MRI alone will be calculated and reported along with the corresponding two-sided 90% confidence intervals constructed by Wilson score method. Subsequent paired McNemar's tests will be used to compare each diagnosis metric based on the two imaging modalities.
- Average signal to noise ratios (SNR) vs. IV FDG dosages will be summarized in plot format. [ Time Frame: 24 months ]
- Logistic regression and a cox proportional hazard model will be generated between hybrid FDG PET/MRI imaging features and tumor biology and tumor recurrence, respectively [ Time Frame: 24 months ]Logistic regression and a cox proportional hazard model will be generated between hybrid FDG PET/MRI imaging features (SUV, T2 characteristics, enhancement pattern, kinetic curve, DWI) and tumor biology (pathological type, receptor status, Ki-67 and oncotype) and tumor recurrence (using a surrogate of Ki-67 and oncotyping when available), respectively.
- Sensitivity in detection of axillary and internal mammary lymph node metastasis between the hybrid breast FDG PET/MRI vs breast MRI alone will be summarized [ Time Frame: 24 months ]
- Perceived patient benefit of undergoing a simultaneous FDG PET/MRI will be summarized [ Time Frame: 24 months ]Subjects will be asked to fill out a questionnaire at the conclusion of their breast PET/MRI exam assessing on a scale of 1 - 7 how important it was for them to save time to do the PET/MRI simultaneously knowing that they may have a negative PET/MRI for extent of disease (no additional sites of disease aside from index cancer), how valuable it is for them to potentially avoid unnecessary biopsies if the study hypothesis is correct, and how important it is to them to decrease delay to surgery.
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): NCT03510988
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Katerina Dodelzon, MD||Weill Medical College of Cornell University|