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ACRIN Gynecologic Committee. Fall Meeting 2010. ACRIN 6695.

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Acrin gynecologic committee l.jpg

ACRIN Gynecologic Committee

Fall Meeting 2010


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ACRIN 6695

Perfusion CT (DCE-CT) as an early predictor of response to combined cytotoxic and anti-angiogenic chemotherapy and as a surrogate marker of long-term outcome for patients with advanced stage epithelial ovarian, peritoneal and fallopian tube cancer: A companion study to GOG 262

Chaan Ng


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  • Overall survival

  • Response

  • Biomarkers in oncology

    • -Assessment of tumor response

    • -Predictors of response

    • -Prognostic markers

  • CEA, PSA, Ca125

  • TNM

  • RECIST

BACKGROUND: Biomarkers


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BACKGROUND: CT Perfusion

  • CT Perfusion

    • Tissue viability

      • Angiogenesis

    • Functional evaluation

      • Tumor blood flow, volume, permeability

    • Combined with routine CT staging


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BACKGROUND: “THE QUESTION”

  • Utility of CT perfusion in oncology

  • Translatability of CT perfusion into clinical environment


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BACKGROUND: THE STUDY

  • ACRIN 6695

  • GOG 262



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“Conventional”

“Dose-dense”

•Primary Endpoint:

-Progression-free survival (PFS)

•Secondary Endpoints:

-Overall Survival (OS)

-Response Rate (RR)

-Toxicity

-Translational Research -Quality of Life


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IMAGING OBJECTIVES: Primary

  • Whether larger changes in tumor perfusion parameters (T2 - T0) are predictive of better progression-free-survival rate at 6 months (PFS6m)

    • [Early predictorof response?]

    • [Prior to first routine CT restaging]



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TARGET LESION

  • Precontrast

    • >1cm short axis

    • > 10 HU on pre-contrast (50% of lesion)

  • Postcontrast

    • > 5 HU enhancement (in 50% of lesion)


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CT CONTRAST

  • Oral contrast

    • Negative or positive contrast

  • IV contrast

    • >300 mgI2/mL

    • 3-4 mL/s

    • 0.8 mL/kg body weight (max. 70 mL volume)




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TARGET LESION

  • > 2cm

  • Round or oval

    • Not plaques

  • Avoid motion

    • Retroperitoneum

    • Pelvis

  • Enhancement

    • Cyst, ascites, hematoma

  • Postop changes


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ELIGIBILITY

  • Eligible for GOG

  • Adequate renal function

  • No contraindication to IV contrast medium

  • Diabetics on Metformin

  • Consent process

    • Correlative within Consent Form of participating GOG sites, with “opt-out”


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ANALYSES

  • Central perfusion CT data analysis

    • Ting Lee

    • ACRIN HQ

  • Data available for alternative analyses

    • GE model

    • Other vendors


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ACCRUAL

  • ACRIN = 70 evaluable

    • GOG = 625

  • Attrition

    • In practice we need 25-30% of GOG accrual


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CHALLENGES

  • Accrual

    • Sites

    • GOG

    • Target lesions

  • Radiationdose


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SITES

  • Looking for collaborating sites


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CONTACT DETAILS

  • Chaan Ng

    • Department of Radiology

    • MD Anderson Cancer Center

    • Houston, TX 77030-4009

    • Phone: 713-792-6759

    • Email:[email protected]

  • Ting-Yim Lee

    • Imaging Research Labs,

    • Robarts Research Institute

    • London, Ontario, Canada

    • Phone: 519-663-5777 ext. 24131

    • Email: [email protected]


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