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Clinical Utility of Combidex in Various Cancers

Clinical Utility of Combidex in Various Cancers. Jelle O. Barentsz, MD Professor of Radiology University Medical Center Nijmegen, Netherlands. Clinical Utility in Cancer. Post-Phase III peer reviewed publications NEJM, Radiology Blinded post-contrast image evaluation with histopathology

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Clinical Utility of Combidex in Various Cancers

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  1. Clinical Utility of Combidexin Various Cancers Jelle O. Barentsz, MD Professor of Radiology University Medical Center Nijmegen, Netherlands

  2. Clinical Utility in Cancer • Post-Phase III peer reviewed publications • NEJM, Radiology • Blinded post-contrast image evaluation with histopathology • Impact on treatment planning • Areas where Combidex MRI provides significantclinicalbenefit • Prostate • Bladder • Head and Neck • Breast

  3. Published Studies

  4. Post-Contrast Results –Published Studies

  5. Prostate Cancer • Current imaging has insufficient sensitivity for LN staging • Surgical LN Sampling • – Samples only a limited area • – 11–31% +LN outside sampled area • – Complications: 22% (open), 5% (lap) • – Lymphocele, lymphedema, DVT, PE, nerve damage, blood loss • Extended LN dissection detects more + LN • but increases morbidity • Zincke (Mayo), Walsh (JHH), Burkhard (Bern)

  6. Prostate CancerImaging Performance – Patient Level NEJM 2003 Harisinghani

  7. Prostate CancerImpact on Treatment Planning 5/80 patients (6%) • Guided needle biopsy for solitary unenlarged (5–8 mm) positive LN on Combidex MRI • All 5 confirmed positive 9/80 patients (11%) • PLND extended outside usual field due to positive LN on Combidex images • All 9 confirmed positive NEJM 2003 Harisinghani

  8. Prostate Cancer 7 mm partly metastatic node outside surgical field Biopsy positive → Androgen ablation

  9. Prostate Cancer Possibly metastatic 1 mm metastasis in LN outside obturator fossa.

  10. Bladder Cancer • 24% LN positive despite negative preoperative imaging • Nodal metastases (N2-3, or >4) radically changestreatment options • Extended LN dissection • – Detects more LN • – Increases survival for minimal disease • – Does not sample all areas of LN • – Increases morbidity • Studer (Switzerland) Skinner (USC) Ghoneim (Egypt)

  11. Bladder CancerImaging Performance – Nodal Level 172 LN (58 patients) • 10/12 normal size positive LNs • seen on post-Combidex MRI only • Radiology 2004 Deserno

  12. Head and Neck Cancer • 5 yr survival 91% (localized) and 63% (regional LN) • Status of cervical LN is vital for choice of therapy • 25% LN positive despite negative preoperative imaging (contrast CT) as metastatic nodes are small (5–10 mm) • Radical neck dissection • – Commonly performed– Results in cosmetic deformity– Complication rate 36–54%

  13. Head and Neck CancerImaging Performance – Nodal Level 1029 LN (27 Patients) • Combidex MRI on LN level accurate in 26/27 (96%) patients • 26% had reduced extent of surgery • Radiology 2002 Mack

  14. Head and Neck Cancer 12 mm node Normal Neck dissection could have been avoided

  15. Breast Cancer • Sentinel Lymph Node Staging (SLN) • – 3–10% false negative • The Sentinel Node is the only positive node in 61% of patients with positive LNs • – These patients all undergo axillary dissection– High rate of clinically significant complications

  16. Breast CancerImaging Performance – Nodal Level • Radiology 2002 Michel 296 LNs (18 Patients)

  17. Breast Cancer Normal Metastatic Sentinel node + Primarytumor

  18. Summary: Clinical Relevance • Current techniques to detect positive LNs in prostate, bladder, head and neck, and breast cancer havesignificant limitations • Combidex MRI shows high sensitivity and specificityin these tumors • Combidex MRI may reduce the extentof surgeryand morbidity • Combidex MRI identifies additional positive LNs for biopsy or image-guided extended dissection (improve staging)

  19. Combidex® (ferumoxtran-10) is for intravenous administration as a contrast agent for use with magnetic resonance imaging (MRI). Combidex can assist in the differentiation of metastatic and non-metastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases. The information provided by Combidex should be considered in conjunction with other diagnostic information and lymph node findings from Combidex images should be pathologically confirmed unless medically contraindicated. Indication

  20. COMBIDEX® (ferumoxtran-10)

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