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ACRIN Gynecologic Committee

ACRIN Gynecologic Committee. Fall Meeting 2010. ACRIN 6695.

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ACRIN Gynecologic Committee

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  1. ACRIN Gynecologic Committee Fall Meeting 2010

  2. 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

  3. Overall survival • Response • Biomarkers in oncology • -Assessment of tumor response • -Predictors of response • -Prognostic markers • CEA, PSA, Ca125 • TNM • RECIST BACKGROUND: Biomarkers

  4. BACKGROUND: CT Perfusion • CT Perfusion • Tissue viability • Angiogenesis • Functional evaluation • Tumor blood flow, volume, permeability • Combined with routine CT staging

  5. BACKGROUND: “THE QUESTION” • Utility of CT perfusion in oncology • Translatability of CT perfusion into clinical environment

  6. BACKGROUND: THE STUDY • ACRIN 6695 • GOG 262

  7. PROTOCOL SCHEMA

  8. “Conventional” “Dose-dense” •Primary Endpoint: -Progression-free survival (PFS) •Secondary Endpoints: -Overall Survival (OS) -Response Rate (RR) -Toxicity -Translational Research -Quality of Life

  9. 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]

  10. Contrast body CT

  11. TARGET LESION • Precontrast • >1cm short axis • > 10 HU on pre-contrast (50% of lesion) • Postcontrast • > 5 HU enhancement (in 50% of lesion)

  12. 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)

  13. TARGET LESION: examples

  14. TARGET LESION: examples

  15. TARGET LESION • > 2cm • Round or oval • Not plaques • Avoid motion • Retroperitoneum • Pelvis • Enhancement • Cyst, ascites, hematoma • Postop changes

  16. 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”

  17. ANALYSES • Central perfusion CT data analysis • Ting Lee • ACRIN HQ • Data available for alternative analyses • GE model • Other vendors

  18. ACCRUAL • ACRIN = 70 evaluable • GOG = 625 • Attrition • In practice we need 25-30% of GOG accrual

  19. CHALLENGES • Accrual • Sites • GOG • Target lesions • Radiationdose

  20. SITES • Looking for collaborating sites

  21. CONTACT DETAILS • Chaan Ng • Department of Radiology • MD Anderson Cancer Center • Houston, TX 77030-4009 • Phone: 713-792-6759 • Email:cng@mdanderson.org • Ting-Yim Lee • Imaging Research Labs, • Robarts Research Institute • London, Ontario, Canada • Phone: 519-663-5777 ext. 24131 • Email: tlee@imaging.robarts.ca

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