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ACRIN Abdominal Committee
ACRIN Gynecologic Committee
ACRIN Gynecologic Committee
Fall Meeting 2010
ACRIN Abdominal Committee
ACRIN Gynecologic Committee
CT Perfusion Study of Ovarian Cancer
ACRIN 6695 Project Team
ACRIN Gynecologic Committee
Study Schedule
Cycle 1 (All cycles 3 weeks in length)
Carboplatin AUC 6 IV day 1 every cycle x 6 cycles
Paclitaxel 80 mg/m2 IV days 1, 8 and 15 every cycle x 6 cycles
Ovarian cancer:
suboptimallydebulked
(e.g. > 1 cm tumor
left behind Surgically)
Cycle 1 (All cycles 3 weeks in length)
Baseline RECIST CT scan & Perfusion CT Baseline (T0)
At least 3 weeks post surgery and within 4 weeks prior to
initiating protocol chemotherapy
Carboplatin AUC 6 IV day 1 every cycle x 6 cycles
Regimen I:
Regimen II:
Bevacizumab 15 mg/kg IV day 1 every cycle starting cycle 2 and continuing beyond cycle 6 until progression or adverse effects preclude further treatment
RANDOMIZE
Follow-up RECIST CT scansafter cycle 3,6,14,22
After completion of all protocol therapy, every 3 months for 2 years,
then every 6 months for 3 years, then annually
Perfusion CT (T2)After one week into cycle 2
Cycle 2
Perfusion CT intermediate (T1)
at end of 1st cycle between 18-21 days
Reproducibility Perfusion CT
A subgroup of patients will be studied
Paclitaxel 175 mg/m2 IV Day 1 every cycle x 6 cycles
Cycle 3 Cycle 4 Cycle 5 Cycle 6
Cycle 2 Cycle 3 Cycle 4 Cycle 5 Cycle 6
Bevacizumab 15 mg/kg IV day 1 every cycle starting cycle 2 and continuing beyond cycle 6 until progression or adverse effects preclude further treatment
ACRIN Gynecologic Committee
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
CT Perfusion Study Protocol
ACRIN Gynecologic Committee
64-slice CT scanner with 40 mm wide detector array without toggling table mode
CT Perfusion Scan Protocol
Inject 300 – 370 mgI/ml contrast
0.8 ml/kg @ 3 – 4 ml/s
40 axial scans @ 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
Effective Dose = 7.2 mSvSkin dose = 150 mGy
ACRIN Gynecologic Committee
64-slice CT scanner with 40 mm wide detector array with toggling table mode
CT Perfusion Scan Protocol
Inject 300 – 370 mgI/ml contrast
0.8 ml/kg @ 3 – 4 ml/s
40 passes @ 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
Effective Dose = 14.3 mSvSkin dose = 150 mGy
ACRIN Gynecologic Committee
128-slice CT scanner with 80 mm wide detector array
CT Perfusion Scan Protocol
Inject 300 – 370 mgI/ml contrast
0.8 ml/kg @ 3 – 4 ml/s
40 axial scans @ 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
Effective Dose = 14.3 mSvSkin dose = 150 mGy
ACRIN Gynecologic Committee
256-slice CT scanner with 120 mm wide detector array
CT Perfusion Scan Protocol
Inject 300 – 370 mgI/ml contrast
0.8 ml/kg @ 3 – 4 ml/s
40 axial scans @ 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
Effective Dose = 17.8 mSvSkin dose = 150 mGy
ACRIN Gynecologic Committee
320-slice CT scanner with 160 mm wide detector array
CT Perfusion Scan Protocol
Inject 300 – 370 mgI/ml contrast
0.8 ml/kg @ 3 – 4 ml/s
40 axial scans @ 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
Effective Dose = 21.4 mSvSkin dose = 150 mGy
ACRIN Gynecologic Committee
Example CT Perfusion Scan of Prostate
Intravenous Injection of
Contrast Agent
60-70 ml @ 3-4 ml/s
Scan ProtocolEach scan: 16 x 5 mm slices @
80 kVp and 50 mAs1 scan every 2.8 s
42 scans
Deco
nvo
lutio
n w
ith p
hysio
l mo
del
Effective dose 21 mSv
-5
0
5
10
15
20
25
30
35
40
0 20 40 60 80 100 120 140
Time (s)
En
han
cem
ent
(HU
)
Artery
0
50
100
150
200
250
0 20 40 60 80 100 120 140
Time (s)
En
han
cem
ent
(HU
)
Average
Blood Volume
Blood Flow
PS
AVG
BF
BV
PS
ACRIN Gynecologic Committee
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
Primary Objective
ACRIN Gynecologic Committee
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
Secondary Objectives
ACRIN Gynecologic Committee
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
Radiation Risk
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
ACRIN Abdominal Committee
ACRIN Gynecologic Committee
Questions ?