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Positron Emission Mammography: Initial Clinical Results

From the Departments of Surgery (EAL, NDP, JL), Radiology (RIF, KM, NML, CS, RCW), and Pathology (SB, KRG), Wake Forest University School of Medicine, Winston-Salem, North Carolina; PEM Technologies Inc. (VZ, INW, PYS, DB), Bethesda, Maryland; Seleon gmbh (KL), Freiburg, Germany; and Department of Nuclear Medicine (MD, LPA), Fox Chase Cancer Center, Philadelphia, Pennsylvania.

Correspondence: Address correspondence and reprint requests to: Edward A. Levine, MD, Surgical Oncology Service, Wake Forest University, Medical Center Blvd., Winston-Salem, NC 27157; Fax : 336-716-9758; E-mail: elevine{at}wfubmc.edu

Background: Evaluation of high-risk mammograms represents an enormous clinical challenge. Functional breast imaging coupled with mammography (positron emission mammography [PEM]) could improve imaging of such lesions. A prospective study was performed using PEM in women scheduled for stereotactic breast biopsy.

Methods: Patients were recruited from the surgical clinic. Patients were injected with 10 mCi of 2-[¹⁸F] fluorodeoxyglucose. One hour later, patients were positioned on the stereotactic biopsy table, imaged with a PEM scanner, and a stereotactic biopsy was performed. Imaging was reviewed and compared with pathologic results.

Results: There were 18 lesions in 16 patients. PEM images were analyzed by drawing a region of interest at the biopsy site and comparing the count density in the region of interest with the background. A lesion-to-background ratio >2.5 appeared to be a robust indicator of malignancy and yielded a sensitivity of 86%, specificity of 91%, and overall diagnostic accuracy of 89%. No adverse events were associated with the PEM imaging.

Conclusions: The data show that PEM is safe, feasible, and has an encouraging accuracy rate in this initial experience. Lesion-to-background ratios >2.5 were found to be a useful threshold value for identifying positive (malignant) results. This study supports the further development of PEM.

Key Words: Mammography • Breast • Imaging • PET • Cancer • Diagnosis

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