Abstract P5-01-13: The Clinical Role and Cost Effectiveness of Breast-Specific Gamma Imaging (BSGI) in the Management of Patients with Negative or Indeterminate Mammographic and Sonographic Findings and an Unresolved Diagnostic Concern

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Abstract Background: BSGI is a molecular imaging technique increasingly used to aid in the management of patients with negative or indeterminate mammograms and an unresolved clinical concern such as indeterminate densities, new vague calcifications, bloody nipple discharge, focal breast pain or palpable masses; especially in those of elevated risk and patients with dense breast tissue. Purpose: This study examines the role and cost effectiveness of BSGI in providing additional information when conventional imaging is indeterminate and greater confidence is required to improve diagnostic accuracy. Methods: This is a retrospective analysis of patients in our practice for whom BSGI was recommended due to an unresolved clinical concern following negative (BI-RADS 1 or2), indeterminate (BI-RADS 0 or 3), or discordant findings on mammography (MMG) or ultrasound (US). For all modalities, the radiologist had the patient's history and imaging studies available to them at the time of interpretation. BSGI studies were classified as negative (BI-RADS 0-3) or positive (BI-RADS 4-5). Biopsy or follow up imaging was performed as recommended by the radiologist. Pathology or 6 month follow up imaging was used as the gold standard and were classified as negative (benign pathology or no evidence of malignancy on follow up imaging) or positive (biopsy proven cancer). Results: There were 95 patients with 102 regions of concern, yielding 15 biopsy proven malignant lesions and 87 benign findings on pathology or follow up imaging. BSGI was positive in 12 malignant and 33 benign lesions and negative in 54 benign lesions, yielding a sensitivity of 80% and a specificity of 62%. The negative predictive value of BSGI in this population was 95%. Conclusion: BSGI contributed significantly to patient management by detecting cancer in 12 of the 95 patients (12.6%). The Medicare reimbursement rate for BSGI in our area is $203.26. Therefore the cost per cancer diagnosis in this population was approximately $1,608.35. If these patients had been sent for breast MRI, $1,026.38 Medicare locally, the cost per diagnosis would rise to $8,129.07. BSGI is a useful, cost effective, complimentary tool in the diagnostic work up of patients when a diagnostic concern remains after negative or indeterminate conventional imaging. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-01-13.

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