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ACRIN Gynecologic Committee. Fall Meeting 2010. CT Perfusion Study of Ovarian Cancer. ACRIN 6695 Project Team. Study Schedule. Regimen I:. Cycle 1 (All cycles 3 weeks in length). Cycle 2. Cycle 3. Cycle 4. Cycle 5. Cycle 6. RANDOMI ZE. Ovarian cancer: suboptimally debulked

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Acrin gynecologic committee

ACRIN Gynecologic Committee

Fall Meeting 2010


Ct perfusion study of ovarian cancer

CT Perfusion Study of Ovarian Cancer

ACRIN 6695 Project Team


Study schedule
Study Schedule

Regimen I:

Cycle1 (All cycles 3 weeks in length)

Cycle 2

Cycle 3

Cycle 4

Cycle 5

Cycle 6

RANDOMI

ZE

Ovarian

cancer:

suboptimally

debulked

(e.g. > 1 cm

tumor

left behind

Surgically)

Carboplatin AUC 6 IV day 1 every cycle x 6 cycles

Paclitaxel 175 mg/m2 IV Day 1 every cycle x 6 cycles

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

Regimen II:

Cycle1 (All cycles 3 weeks in length)

Cycle 2

Cycle 3

Cycle 4

Cycle 5

Cycle 6

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

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

Perfusion CT

intermediate (T1)

at end of 1st cycle between 18-21 days

Reproducibility Perfusion CT

A subgroup of patients will be studied

Follow-up RECIST CT scans

after 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

Baseline RECIST CT scan & Perfusion CT Baseline (T0)

At least 3 weeks post surgery

and within 4 weeks prior to

initiating protocol chemotherapy

Perfusion CT (T2)

After one week into cycle 2


Ct perfusion study protocol
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


Ct perfusion scan protocol
CT Perfusion Scan Protocol

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

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

          

Inject 300 – 370 mgI/ml contrast

0.8 ml/kg @ 3 – 4 ml/s

Effective Dose = 7.2 mSv

Skin dose = 150 mGy


Ct perfusion scan protocol1
CT Perfusion Scan Protocol

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

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

          

Inject 300 – 370 mgI/ml contrast

0.8 ml/kg @ 3 – 4 ml/s

Effective Dose = 14.3 mSv

Skin dose = 150 mGy


Ct perfusion scan protocol2
CT Perfusion Scan Protocol

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

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

          

Inject 300 – 370 mgI/ml contrast

0.8 ml/kg @ 3 – 4 ml/s

Effective Dose = 14.3 mSv

Skin dose = 150 mGy


Ct perfusion scan protocol3
CT Perfusion Scan Protocol

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

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

          

Inject 300 – 370 mgI/ml contrast

0.8 ml/kg @ 3 – 4 ml/s

Effective Dose = 17.8 mSv

Skin dose = 150 mGy


Ct perfusion scan protocol4
CT Perfusion Scan Protocol

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

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

          

Inject 300 – 370 mgI/ml contrast

0.8 ml/kg @ 3 – 4 ml/s

Effective Dose = 21.4 mSv

Skin dose = 150 mGy


Example ct perfusion scan of prostate

Average

AVG

Blood Flow

BF

BV

Blood Volume

PS

PS

Deconvolution with physiol model

Example CT Perfusion Scan of Prostate

Effective dose 21 mSv

Intravenous Injection of Contrast Agent

60-70 ml @

3-4 ml/s

Scan Protocol

Each scan: 16 x 5 mm slices @ 80 kVp and 50 mAs

1 scan every 2.8 s

42 scans


Primary objective
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


Secondary objectives
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


Radiation risk
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



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