Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dedicated Breast PET/MRI in Evaluation of Extent of Disease in Women With Newly Diagnosed Breast Cancer

Conditions
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Newly Diagnosed Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Hybrid breast FDG PET/MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with newly diagnosed breast cancer<br>Women with newly diagnosed breast cancer recruited for hybrid dedicated breast PET/MRI for extent of disease staging prior to management in lieu of breast MRI alone. IV FDG and Gadolinium was injected once prior to the study as per protocol and weight. In each second consecutively recruited patient FDG dosage was decreased by 20% up to 40% of weight-based dosage to ascertain feasibility of imaging at lower FDG dosages. IV Gadolinium was injected once with weight dependent dosages as per clinical standard of care. | Diagnostic Test: Hybrid breast FDG PET/MRI<br>* Hybrid breast FDG PET/MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Blinded radiologists evaluated a list of anonymized studies of breast MRI alone and after washout period the same MRI with ovelayed PET from a hybrid PETMRI study cohort and asked to assess lesions suspicious for malignancy in addition to known index tumor. Measures of diagnostic accuracy( sensitivity, specificity, PPV and NPV) for any and all additional lesions exclusive of the known index tumor detected by readers were calculated for MRI alone and for PET/MRI. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake. Sensitivity is the % of true positive & specificity is the % of true negative. PPV is the probability that if imaging was assessed as suspicious on biopsy was malignant. NPV is the % likelihood that if imaging was assessed as negative there was no additional malignancy on surgical excision. | 24 months post-intervention | 
| Average Signal to Noise Ratios (SNR) vs. IV FDG Dosages Will be Summarized in Plot Format. | PET imaging was assessed for signal-to-noise ratio of maximum standardized uptake value (SUVmax) over the breast background SUVmean. This is compiled below for each administered dose of FDG. Each subject received one FDG and one gadolinium dose IV injection. | 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 | 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 nodal disease as a whole (present/absent). Sensitivity, specificity, PPV (positive predictive value), and NPV (negative predictive value) of nodal metastasis (presence or absence) of hybrid breast FDG PET/MRI vs breast MRI alone were compared. Due to washout period readers assessed the imaging of hybrid PET/MRI in complement, as such readers may assess previously questioned MRI findings as benign in the absence of FDG uptake. | 24 months post-intervention | 
| Perceived Patient Benefit of Undergoing a Simultaneous FDG PET/MRI Will be Summarized | Subjects will be asked to fill out a questionnaire at the conclusion of their breast PET/MRI exam assessing on a scale of 1 - 5 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. | 24 months post-intervention |