Alexander Poellinger MD, Presenter: Nothing to Disclose

Thorsten Persigehl MD, Abstract Co-Author: Nothing to Disclose

Felix Diekmann MD, Abstract Co-Author: Research Grant, Bayer AG Research Grant, Koninklijke Philips Electronics NV

Steven L. L. Ponder, Abstract Co-Author: Director, Imaging Diagnostic Systems, Inc

Marianne Mahler, Abstract Co-Author: Research Consultant, Mivenion GmbH

Malte Bahner, Abstract Co-Author: Managing Director, Mivenion GmbH

Christoph B. Bremer MD, Abstract Co-Author: Nothing to Disclose

To evaluate the efficacy of the near-infrared fluorescence dye Omocianine in a placebo-controlled, dose-escalating multi-center trial for the detection of malignant breast lesions by using a Computed Tomography Laser Mammography (CTLM) system.

Following IRB approval and written informed consent, 52 patients with 53 suspicious target lesions (BIRADS 4 or 5) were examined with dose-escalating injections of 0.01 to 0.5 mg/kg Omocianine (Schering AG, Berlin Germany). Three-dimensional absorption and fluorescence diffuse optical tomography (DOT) scans were recorded simultaneously on a CTLM scanner (Imaging Diagnostic Systems, Fort Lauderdale, FL). Lesion detection rates were assessed for absorption and fluorescence images by two radiologists in consensus. Imaging results were compared with histopathologic findings. Lesion detection rates were further compared to the lesion size, transverse breast diameter at the location of the lesion, and shortest diameter to the skin.

Histological analysis revealed 22 benign and 31 malignant lesions. In the absorption mode, an overall detection rate of 11.8% for benign and 44.4% for malignant lesions was found. In the fluorescence mode, the detection rate reached 17.6% for benign and 55.6% for malignant lesions across all dose groups. Dose group 0.1 mg/kg showed a detection rate of 100% for malignant lesions in the fluorescence mode and 71.4% in the absorption mode. Lesion detection of Omocianine-enhanced fluorescence DOT depended on lesion-skin distance (< 20 mm: 63.6%, < 30 mm: 47.4%, ≥ 30 mm: 25%). Malignant target lesions with a diameter ≥ 20 mm were slightly better detected (61.5%) compared to lesions < 20 mm (53.8%)  

Our preliminary data suggest that fluorescence imaging after Omocianine administration can be used to detect malignant breast lesions by CTLM. In this study detection rate for invasive breast cancers was variable depending on dose, size, and location. Thus further studies are warranted to assess the suitable dose for NIR imaging and the applicability of this technology for clinical use.

Fluorescence breast imaging might serve as adjunct to x-ray mammography for detection and differentiation of breast lesions.

Poellinger, A, Persigehl, T, Diekmann, F, Ponder, S, Mahler, M, Bahner, M, Bremer, C, Near-Infrared Imaging of the Breast Using Omocianine as a Fluorescent Dye: Results of a Placebo-controlled, Clinical Multicenter Trial.  Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL. http://archive.rsna.org/2011/11012728.html