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Mechanism of Action Combidex in MR Imaging

Mechanism of Action Combidex in MR Imaging. Mukesh Harisinghani, MD Department of Radiology, Massachusetts General Hospital. Overview. Current limitations for LN staging in cancer Combidex enhanced MRI Mechanism of action

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Mechanism of Action Combidex in MR Imaging

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  1. Mechanism of Action Combidex in MR Imaging Mukesh Harisinghani, MD Department of Radiology, Massachusetts General Hospital

  2. Overview • Current limitations for LN staging in cancer • Combidex enhanced MRI • Mechanism of action • Fulfills unmet clinical need of staging LN in patientswith known primary cancer

  3. Why Image Lymph Nodes? • Accurate staging of the primary cancerAppropriate treatment • Prostate Cancer • LN Positive  Treatment changed to non-surgical • Get a sense of the prognosis • Bladder Cancer • Node Negative  10-year survival 57–87% • Node Positive  5-year survival 35–38% Risk of death increases 20% with each additional + LN Cheville et al. Cancer 97, 2003.

  4. Current LN Staging • Non-Invasive • Imaging • Invasive • Surgical LN Sampling (gold standard)

  5. Size Criteria < 10 mm Benign < 8 mm > 10 mm Malignant > 8 mm

  6. Benign Malignant Size criterion is inaccurate 18 mm in short axis 5 mm in short axis

  7. Morphology – Fatty Hilum Benign Malignant

  8. Morphology – Central Necrosis • CT in Cervical Cancer • Positive predictive valueof 100% for nodal metastases • Most necrotic nodes haddiameter > 2 cm Yang et al. AJR 2000;175.

  9. Pelvic Lymphadenectomy • Pelvic lymph node dissection (PLND) accompanied by frozen section pathological examination • Standard pelvic lymphadenectomyis limited • Extended pelvic lymphadenectomy • Incidence of lymph node metastases increased from 10% to 26.2% Heidenreich et al. J Urol. April 2002.

  10. Extended lymph node dissection • Obturator nerve injury • Trauma to major vessels Narayan et al. Urology 1994;44:519–24. • Frozen section pathologic analysis has false negative rate of 30–40% • Young et al. J Clin Path 52,1999.

  11. Current Need • Non-invasive technique that detects andcharacterizes LN with high degreeof sensitivity and specificity • Broad anatomic coverage for all LN

  12. Combidex (ferumoxtran-10) Nanoparticles Size: 21 nm R1: 17 mMsec-1 R2: 48 mMsec-1

  13. Combidex (ferumoxtran-10) Uptake by normal lymph nodes

  14. Technique • 1.5 T MR systems using pelvic phasearray coil (Siemens Magnetom, GE Horizon) • Imaging time/sequences (25 minutes/patient) • T2 FSE sequences • T2* gradient echo sequences • 3D gradient echo sequences • Post-processing • 3D reconstruction

  15. 24 hours Post-contrast Pre-contrast

  16. 20 mm

  17. Unenhanced MR Combidex enhanced MR

  18. Clinical Impact • Improved clinical staging • Surgical planning • Radiation therapy planning • Image-guided intervention

  19. COMBIDEX® (ferumoxtran-10)

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