ACRIN Gynecologic Committee

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ACRIN Gynecologic Committee

• Fall Meeting 2010

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CT Perfusion Study of Ovarian Cancer

• ACRIN 6695 Project Team

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Study Schedule
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CT Perfusion Study Protocol

• Scout to define limits of localization scan
• Localization scan
• Use site abdominal scan protocol
• Define limits of tumor, either 4 or 8 cm slab
• If follow-up study, try locate the same tumor
  slices as the initial baseline study
• CT Perfusion scan as per protocol
• GE Healthcare scanner - non axial shuttle mode
• GE Healthcare scanner axial shuttle mode
• Toshiba Aquilion One scanner
• No breath-hold, patient is instructed to breath
  normally during scan
• Contrast dose
• 0.7 ml per kg body weight up to a max of 65 ml
• Injection rate 3-4 ml per second
• Radiation dose
• 4 cm coverage 9.5 mSv
• 8 cm coverage 16.8 mSV

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CT Perfusion Scan Protocol

• 64-slice CT scanner with 40 mm wide detector
  array without toggling table mode

40 axial scans _at_ 2.8 - 3 s intervals 120 kVp
100 mA 8 x 5 mm slices 0.4 s rotation period
0s 3 6 9 12

114 117 120s

1 2 3 4 ?
? ? ?
? ? ? ?
? ? ? 38 39
40
? ? ? ? ? ? ? ?
? ? ?
Inject 300 370 mgI/ml contrast 0.8 ml/kg
_at_ 3 4 ml/s
Effective Dose 7.2 mSv Skin dose 150 mGy
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CT Perfusion Scan Protocol

• 64-slice CT scanner with 40 mm wide detector
  array with toggling table mode

40 passes _at_ 2.8 - 3 s intervals 120 kVp 100 mA
16 x 5 mm slices 0.4 s rotation period
0s 3 6 9 12

114 117 120s

1 2 3 4 ?
? ? ?
? ? ? ?
? ? ? 38 39
40
? ? ? ? ? ? ? ?
? ? ?
Inject 300 370 mgI/ml contrast 0.8 ml/kg
_at_ 3 4 ml/s
Effective Dose 14.3 mSv Skin dose 150 mGy
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CT Perfusion Scan Protocol

• 128-slice CT scanner with 80 mm wide detector
  array

40 axial scans _at_ 2.8 - 3 s intervals 120 kVp
100 mA 16 x 5 mm slices 0.4 s rotation period
0s 3 6 9 12

114 117 120s

1 2 3 4 ?
? ? ?
? ? ? ?
? ? ? 38 39
40
? ? ? ? ? ? ? ?
? ? ?
Inject 300 370 mgI/ml contrast 0.8 ml/kg
_at_ 3 4 ml/s
Effective Dose 14.3 mSv Skin dose 150 mGy
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CT Perfusion Scan Protocol

• 256-slice CT scanner with 120 mm wide detector
  array

40 axial scans _at_ 2.8 - 3 s intervals 120 kVp
100 mA 20 x 5 mm slices 0.4 s rotation period
0s 3 6 9 12

114 117 120s

1 2 3 4 ?
? ? ?
? ? ? ?
? ? ? 38 39
40
? ? ? ? ? ? ? ?
? ? ?
Inject 300 370 mgI/ml contrast 0.8 ml/kg
_at_ 3 4 ml/s
Effective Dose 17.8 mSv Skin dose 150 mGy
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CT Perfusion Scan Protocol

• 320-slice CT scanner with 160 mm wide detector
  array

40 axial scans _at_ 2.8 - 3 s intervals 120 kVp
100 mA 24 x 5 mm slices 0.4 s rotation period
0s 3 6 9 12

114 117 120s

1 2 3 4 ?
? ? ?
? ? ? ?
? ? ? 38 39
40
? ? ? ? ? ? ? ?
? ? ?
Inject 300 370 mgI/ml contrast 0.8 ml/kg
_at_ 3 4 ml/s
Effective Dose 21.4 mSv Skin dose 150 mGy
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Example CT Perfusion Scan of Prostate
Deconvolution with physiol model
Effective dose 21 mSv
Intravenous Injection of Contrast Agent 60-70 ml
_at_ 3-4 ml/s
Scan Protocol Each scan 16 x 5 mm slices _at_ 80
kVp and 50 mAs 1 scan every 2.8 s 42 scans
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Primary Objective

• To determine whether larger changes in the tumor
  perfusion parameters (BF, BV, MTT, PS) from
  baseline T0 to T2 are predictive of higher
  progression-free survival (PFS) rate at 6 months
  in patients treated with weekly paclitaxel
  regimen or every-3-week paclitaxel regimen, who
  are receiving carboplatin with or without
  bevacizumab

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Secondary Objectives

• To determine whether larger changes in tumor
  perfusion parameters from baseline T0 to T1 are
  predictive of higher progression-free survival
  (PFS) rate at 6 months in patients treated with
  weekly paclitaxel regimen or every-3-week
  paclitaxel regimen, who are receiving carboplatin
  with or without bevacizumab
• To determine whether larger changes in tumor
  perfusion parameters values from T0 to T1, T0 to
  T2 and T1 to T2 are predictive of better overall
  survival in all treatment arms.
• To assess the association between changes in
  tumor perfusion parameters before and after
  chemotherapy and subsequent best tumor response
  according to standard anatomic response
  evaluation criteria (RECIST).
• To assess the association between tumor perfusion
  parameters before chemotherapy and subsequent
  best tumor response according to standard
  anatomic response evaluation criteria (RECIST),
  progression free survival at 6 months and overall
  survival.
• To test the assumption that tumor perfusion
  parameters are reliable, user-independent and
  reproducible parameters of tumor microvascular
  characteristics. A subgroup of 15 patients will
  have repeat CT Perfusion studies at T1 to achieve
  this objective

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Radiation Risk

• Radiation Dose
• Effective dose
• Research plus normal care 87.2 mSv
• Annual background 3.0 mSv
• Cancer induction and fatality risk
• BEIR VII report
• Committee to Assess Health Risks from Exposure to
  Low Levels of Ionizing Radiation, National
  Research Council

Excess cases of cancer (all solid cancers and leukemia including non-fatal cases) from ONE DCE-CT study per 100,000 exposed 1,195
Number of cancer cases per 100,000 in the general population not exposed to radiation 37,490
Excess cases of cancer death from ONE CT Perfusion study per 100,000 exposed 576
Number of cancer deaths per 100,000 in the general population not exposed to radiation 18,030
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Questions ?