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ACRIN 6671 / GOG 0233 FERUMOXTRAN-10 MRI REVIEW RESULTS ACRIN PI: M. ATRI GOG PI: M. GOLD

ACRIN 6671 / GOG 0233 FERUMOXTRAN-10 MRI REVIEW RESULTS ACRIN PI: M. ATRI GOG PI: M. GOLD. Zhang Z, Marques H, Gorelick J, Harisinghani M, Sohaib A, Koh DM, Raman S, Gee M, Choi H, Landrum L, Manne R, Chuang L, Yu J, McCourt C.

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ACRIN 6671 / GOG 0233 FERUMOXTRAN-10 MRI REVIEW RESULTS ACRIN PI: M. ATRI GOG PI: M. GOLD

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  1. ACRIN 6671/GOG 0233 FERUMOXTRAN-10 MRIREVIEW RESULTSACRIN PI: M. ATRIGOG PI: M. GOLD Zhang Z, Marques H, Gorelick J, Harisinghani M, Sohaib A, Koh DM, Raman S, Gee M, Choi H, Landrum L, Manne R, Chuang L, Yu J, McCourt C

  2. Ferumoxtran-10 nanoparticle, an ultra-small particle iron oxide (USPIO) agent improves sensitivity/specificity of MRI to detect metastatic lymphadenopathy Harisinghani et al. showed a per patient sensitivity/specificity of 100%/96% for LN detection in 80 prostate cancer patients Rockall et al. showed significantly higher sensitivity than size criteria without compromise of specificity in 44 endometrial and cervical cancer patients INTRODUCTION

  3. To determine efficacy of f-10 in the evaluation of LN metastasis from loco-regionally advanced cervical cancer OBJECTIVE

  4. Loco-regionally advanced CA Pre-operative MRI 24-36hrs post f-10 Extra-peritoneal/laparoscopic abdominal & pelvic lymph node sampling Per region comparison of lymphadenectomy and f-10 MRI for 8 regions: Rt. & Lt. para-aortic Rt. & Lt. common iliac Rt. & Lt. external iliac Rt. & Lt. obturator ABDOMEN PELVIS STUDY DESIGN

  5. 33 women 30 – 67 year (mean 49 ±11) Primary tumor: 5.4 cm ±1.5 cm Disease Stage: IB2:12, IIA:3, IIB:15, IIIB:3 Pathology: Squamous cell;29, Adenoca;3, Rhabdomyosarcoma;1 Grade: 1 (1), grade 2 (20), grade 3 (12) STUDY POPULATION

  6. 1.5 Tesla MRI, pelvic phased array coil Coverage from IMA origin to symphysis pubis 2.6 mg/kg of f-10 diluted in 100 ML of normal saline (IND agent, IND held by NCI) (provided by AMAG Inc.) Infused over 30 minutes T1W, T2W, and T2*GRE sequences MRI EXAMINATION

  7. Independent review by seven readers 1st Review: All sequences excluding T2* GRE sequence Lymph node positive: short axis > 8mm for a node with short axis > half of long short axis > 10mm for a node with short axis < half of long 2nd. Review: All sequences including T2* GRE sequence Lymph node positive: High signal LN or high signal foci within LN MRI REVIEW PROCESS

  8. Institutional pathology review Presence/absence of LN metastasis, size of the largest focus of metastasis/region, size of the largest positive LN/region recorded PATHOLOGY REVIEW

  9. Degree of suspicion of LN metastasis recorded on a 6 point scale Test result dichotomized to positive/negative using top or bottom 3 scores to calculate sensitivity/specificity Abdomen or pelvis positive if one or more region was positive in abdomen or pelvis on the same side on MRI and surgery STATISTICAL ANALYSIS

  10. Prevalence of LN metastasis Abdomen: 36% (12/33) Pelvis: 64% (21/33) Median size of the largest focus of cancer 18mm (range 2–50mm) Mean size of the largest focus Abdomen (13.7mm) Pelvis (18.8mm) P value(0.018) RESULTS

  11. RESULTS

  12. RESULTS

  13. RESULTS

  14. INTER-OBSERVER AGREEMENT

  15. T2W T2*

  16. T2W T2*

  17. T2W T2*

  18. Results of this study suggests higher sensitivity of ferumoxtran-10 MRI over standard MRI that did not reach statistical significance Specificity of ferumoxtran-10 MRI was significantly lower than standard MRI Lower specificity may be due to issues related to mismatching of metastatic LNs on MRI and surgery and lack of removal of involved LNs SUMMARY

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