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2011 ACRIN Annual Meeting
ACRIN 6671ACRIN 6671//GOG 0233GOG 0233
FERUMOXTRAN-10 MRI REVIEW REVIEW RESULTSRESULTS
ACRIN PI: M. ATRIACRIN PI: M. ATRIGOG PI: M. GOLDGOG PI: M. GOLD
Zhang Z, Marques H, Gorelick J, Harisinghani M, Sohaib A, Zhang Z, Marques H, Gorelick J, Harisinghani M, Sohaib A, Koh DM, Raman S, Gee M, Choi H, Landrum L, Manne R, Koh DM, Raman S, Gee M, Choi H, Landrum L, Manne R,
Chuang L, Yu J, McCourt CChuang L, Yu J, McCourt C
2011 ACRIN Annual Meeting
• Ferumoxtran-10 nanoparticle, an ultra-small Ferumoxtran-10 nanoparticle, an ultra-small particle iron oxide (USPIO) agent improves particle iron oxide (USPIO) agent improves sensitivity/specificity of MRI to detect metastatic sensitivity/specificity of MRI to detect metastatic lymphadenopathylymphadenopathy
• Harisinghani et al. showed a per patient Harisinghani et al. showed a per patient sensitivity/specificity of 100%/96% for LN detection sensitivity/specificity of 100%/96% for LN detection in 80 prostate cancer patientsin 80 prostate cancer patients
• Rockall et al. showed significantly higher Rockall et al. showed significantly higher sensitivity than size criteria without compromise of sensitivity than size criteria without compromise of specificity in 44 endometrial and cervical cancer specificity in 44 endometrial and cervical cancer patientspatients
INTRODUCTIONINTRODUCTION
2011 ACRIN Annual Meeting
• To determine efficacy of f-10 in the evaluation of LN metastasis from loco-regionally advanced cervical cancer
OBJECTIVEOBJECTIVE
2011 ACRIN Annual Meeting
STUDY DESIGNSTUDY DESIGN
• Loco-regionally advanced CALoco-regionally advanced CA• Pre-operative MRI 24-36hrs post f-10Pre-operative MRI 24-36hrs post f-10• Extra-peritoneal/laparoscopic abdominal & Extra-peritoneal/laparoscopic abdominal &
pelvic lymph node samplingpelvic lymph node sampling• Per regionPer region comparison of lymphadenectomy comparison of lymphadenectomy
and f-10 MRI for 8 regions:and f-10 MRI for 8 regions:• Rt. & Lt. para-aortic Rt. & Lt. para-aortic • Rt. & Lt. common iliac Rt. & Lt. common iliac • Rt. & Lt. external iliacRt. & Lt. external iliac• Rt. & Lt. obturator Rt. & Lt. obturator
ABDOMENABDOMEN
PELVISPELVIS
2011 ACRIN Annual Meeting
STUDY POPULATIONSTUDY POPULATION
• 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)
2011 ACRIN Annual Meeting
• 1.5 Tesla MRI, pelvic phased array coil1.5 Tesla MRI, pelvic phased array coil
• Coverage from IMA origin to symphysis Coverage from IMA origin to symphysis pubispubis
• 2.6 mg/kg of f-10 diluted in 100 ML of 2.6 mg/kg of f-10 diluted in 100 ML of normal saline (IND agent, IND held by normal saline (IND agent, IND held by NCI) (provided by AMAG Inc.) NCI) (provided by AMAG Inc.)
• Infused over 30 minutesInfused over 30 minutes
• T1W, T2W, and T2*GRE sequencesT1W, T2W, and T2*GRE sequences
MRI EXAMINATIONMRI EXAMINATION
2011 ACRIN Annual Meeting
• Independent review by seven readers• 1st Review: All sequences excluding T2*
GRE sequence • Lymph node positive:Lymph node positive:
• short axis > 8mm for a node with short axis > half of longshort axis > 8mm for a node with short axis > half of long• short axis > 10mm for a node with short axis < half of longshort axis > 10mm for a node with short axis < half of long
• 2nd. Review: All sequences including T2* GRE sequence• Lymph node positive:Lymph node positive:
• High signal LN or high signal foci within LN
MRI REVIEW PROCESSMRI REVIEW PROCESS
2011 ACRIN Annual Meeting
• 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 REVIEWPATHOLOGY REVIEW
2011 ACRIN Annual Meeting
• 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 ANALYSISSTATISTICAL ANALYSIS
2011 ACRIN Annual Meeting
• Prevalence of LN metastasis Prevalence of LN metastasis Abdomen: 36% (12/33) Abdomen: 36% (12/33)
Pelvis: 64% (21/33)Pelvis: 64% (21/33)• Median size of the largest focus of cancer Median size of the largest focus of cancer
18mm (range 2–50mm) 18mm (range 2–50mm)• Mean size of the largest focus Mean size of the largest focus
Abdomen (13.7mm) Abdomen (13.7mm) Pelvis (18.8mm) Pelvis (18.8mm)
P valueP value (0.018)(0.018)
RESULTSRESULTS
2011 ACRIN Annual Meeting
RESULTSRESULTS
MRI Accuracy Values
T2* Insensitive Sequences
All
Sequences
P Value
Range Average Range Average
P
E
L
V
I
S
Sensitivity 0.76-0.81 0.78 (0.70-0.84) 0.71-0.90 0.83 (0.76-0.88) 0.243
Specificity 0.56-0.89 0.75 (0.62-0.84) 0.22-0.67 0.48 (0.35-0.61) 0.003
NPV 0.50-0.64 0.59 (0.48-0.69) 0.25-0.67 0.55 (0.41-0.67) 0.629
PPV 0.80-1.00 0.88 (0.81-0.92) 0.68-0.85 0.79 (0.72-0.84) 0.049
Accuracy 0.70-0.80 0.77 (0.70-0.82) 0.57-0.77 0.72 (0.66-0.78) 0.315
A
B
D
O
M
E
N
Sensitivity 0.50-0.58 0.54 (0.43-0.64) 0.50-0.75 0.60 (0.49-0.70) 0.438
Specificity 0.68-0.89 0.83 (0.75-0.88) 0.58-0.89 0.75 (0.67-0.82) 0.136
NPV 0.70-0.76 0.74 (0.66-0.80) 0.69-0.83 0.75 (0.67-0.81) 0.878
PPV 0.54-0.75 0.66 (0.54-0.76) 0.47-0.75 0.60 (0.49-0.70) 0.454
Accuracy 0.65-0.74 0.71 (0.65-0.77) 0.58-0.77 0.69 (0.63-0.75 ) 0.600
2011 ACRIN Annual Meeting
RESULTSRESULTS
MRI Accuracy Values
T2* Insensitive Sequences
All
Sequences
P Value
Range Average Range Average
P
E
L
V
I
S
Sensitivity 0.76-0.81 0.78 (0.70-0.84) 0.71-0.90 0.83 (0.76-0.88) 0.243
Specificity 0.56-0.89 0.75 (0.62-0.84) 0.22-0.67 0.48 (0.35-0.61) 0.003
NPV 0.50-0.64 0.59 (0.48-0.69) 0.25-0.67 0.55 (0.41-0.67) 0.629
PPV 0.80-1.00 0.88 (0.81-0.92) 0.68-0.85 0.79 (0.72-0.84) 0.049
Accuracy 0.70-0.80 0.77 (0.70-0.82) 0.57-0.77 0.72 (0.66-0.78) 0.315
A
B
D
O
M
E
N
Sensitivity 0.50-0.58 0.54 (0.43-0.64) 0.50-0.75 0.60 (0.49-0.70) 0.438
Specificity 0.68-0.89 0.83 (0.75-0.88) 0.58-0.89 0.75 (0.67-0.82) 0.136
NPV 0.70-0.76 0.74 (0.66-0.80) 0.69-0.83 0.75 (0.67-0.81) 0.878
PPV 0.54-0.75 0.66 (0.54-0.76) 0.47-0.75 0.60 (0.49-0.70) 0.454
Accuracy 0.65-0.74 0.71 (0.65-0.77) 0.58-0.77 0.69 (0.63-0.75 ) 0.600
2011 ACRIN Annual Meeting
MRI Accuracy Values
T2* Insensitive
Sequences
All
Sequences
P Value
Range Average Range Average
C
O
M
B
I
N
E
D
Sensitivity 0.78-0.83 0.80 (0.73-0.85) 0.78-0.96 0.86 (0.79-0.90) 0.144
Specificity 0.63-0.88 0.73 (0.60-0.83) 0.25-0.63 0.43 (0.30-0.56) 0.002
NPV 0.50-0.60 0.55 (0.44-0.66) 0.29-0.67 0.51 (0.37-0.65) 0.642
PPV 0.86-0.95 0.90 (0.83-0.94) 0.75-0.87 0.81 (0.75-0.86) 0.043
Accuracy 0.74-0.81 0.78 (0.72-0.83) 0.65-0.81 0.75 (0.68-0.80) 0.430
RESULTSRESULTS
2011 ACRIN Annual Meeting
INTER-OBSERVER AGREEMENTINTER-OBSERVER AGREEMENT
Comparison
of All Readers
T2* Insensitive Sequences
All
SequencesKappa P Value Kappa P Value
Abdomen 0.74 < 0.0001 0.54 < 0.0001
Pelvis 0.84 < 0.0001 0.52 < 0.0001
Combined 0.89 < 0.0001 0.46 < 0.0001
2011 ACRIN Annual Meeting
T2W
T2*
2011 ACRIN Annual Meeting
T2W
T2*
2011 ACRIN Annual Meeting
T2*
T2W
2011 ACRIN Annual Meeting
• Results of this study suggests higher Results of this study suggests higher sensitivity of ferumoxtran-10 MRI over sensitivity of ferumoxtran-10 MRI over standard MRI that did not reach statistical standard MRI that did not reach statistical significancesignificance
• Specificity of ferumoxtran-10 MRI was Specificity of ferumoxtran-10 MRI was significantly lower than standard MRIsignificantly lower than standard MRI
• Lower specificity may be due to issues Lower specificity may be due to issues related to mismatching of metastatic LNs on related to mismatching of metastatic LNs on MRI and surgery and lack of removal of MRI and surgery and lack of removal of involved LNsinvolved LNs
SUMMARY