Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Newly Diagnosed Breast Cancer
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a single institution study enrolling women over age 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care. Subjects will undergo a hybrid dedicated Breast PET/MRI in lieu of a breast MRI alone, for evaluation of extent of disease prior to surgical and oncologic management. The study will investigate any incremental added benefit to breast MRI specificity by the addition of concurrent hybrid breast PET.
Detailed Description
The study hypothesis is that the combination of Breast PET/MRI, will improve specificity and decrease the number of false positive breast biopsies recommended based on breast MRI findings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women over age of 25 with newly diagnosed breast cancer and for whom a breast MR has been ordered as standard of care
Exclusion Criteria
- •Male subjects
- •Women younger than 25
- •Pregnant subjects
- •Unable or unwilling to undergo MRI
- •Previous adverse reaction to 18F-FDG
- •Unwilling to undergo biopsy of MRI positive lesions
Outcomes
Primary Outcomes
Specificity of the PET-MRI Compared to MRI Alone as Assessed by the Percentage of True Negatives Out of All Benign/Non-malignant Lesions Breast Cancer
Time Frame: 24 months
Blinded breast imaging readers were provided at random a reading list of anonymized studies of breast PET/MRIs and MRI alone from the study cohort and asked to assess lesions suspicious for malignancy. Specificity of all lesions on PET-MRI compared to MRI alone is assessed by the percentage of true negatives out of all benign/non-malignant lesions.
Secondary Outcomes
- Sensitivity, PPV (Positive Predictive Value), and NPV (Negative Predictive Value) 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.(24 months post-intervention)
- Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format.(24 months post-intervention)
- Number of Interval Recurrences(24 months post-intervention)
- 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(24 months post-intervention)
- Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized(24 months post-intervention)