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ACRIN Activates Four Trials The American College of Radiology Imaging Network is pleased to announce the recent activation of four clinical trials to include: An advanced MRI substudy carried out at qualified sites participating in the RTOG 0825 trial: Phase III ChemoXRT/TMZ with Bevacizumab or Placebo in Participants with Newly Diagnosed Glioblastom ACRIN 6686: A. Gregory Sorensen, MD ACRIN Principal Investigator Mark Gilbert, MD RTOG Study Chair Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18FFluoromisonidazole (FMISO) With PET and MRI ACRIN 6684: A Multicenter, A. Gregory Sorensen, MD ACRIN Co-Principal Investigator David Mankoff, MD, PhD ACRIN Co- Principal Investigator ACRIN 6688: Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast Cancer David Mankoff, MD, PhD ACRIN Co- Principal Investigator Lale Kostakoglu, MD, MPH ACRIN Co-Principal Investigator Paul R. Jolles, MD VCU Study Chair A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib, a Src Kinase Inhibitor, in Men with Castration-Resistant Prostate Cancer and Bone Metastases ACRIN 6687: Evan Y. Yu, MD ACRIN Principal Investigator Phillip G. Febbo, MD Study Chair Information about trial objectives, site participation requirements, and links to more information are included in the attached document. Announcing Recently Activated Clinical Trials Head/Neck/Neuro Committee Trial An advanced MRI substudy carried out at qualified sites participating in the RTOG 0825 trial: Phase III ChemoXRT/TMZ with Bevacizumab or Placebo in Participants with Newly Diagnosed Glioblastoma ACRIN 6686: assess the association between overall survival and Ktrans change from T1 to T2 and to assess the association between overall survival and spin echo cerebral blood volume changes from T1 to T2. Primary Objectives: To Pre-qualification of imaging scanners and images is required at RTOG sites wishing to participate in the advanced-imaging component. All eligible potential participants recruited at advanced-imaging sites must be asked to consent to additional imaging comprised of four dynamic susceptibility contrast and dynamic contrast enhanced-MRI scans. Target accrual 264 participants of the 720 RTOG 0825 study. Site Requirements: Contact project manager Bernadine Dunning ([email protected]); 215574-3228) or visit www.acrin.org/TabID/603/Default.aspx . More Information: Head/Neck/Neuro Committee Trial in Collaboration with the Experimental Imaging Sciences Committee Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18FFluoromisonidazole (FMISO) With PET and MRI ACRIN 6684: A Multicenter, To determine the association of FMISO PET uptake (tumor to blood ratio and hypoxic volume) and MRI parameters (Ktrans and cerebral blood volume) with overall survival in participants with newly diagnosed glioblastoma. Primary Objective: For this pilot study, five to ten sites are anticipated to enroll 50 adult participants. Sites must be located within the delivery region of the radiopharmacy producing the FMISO agent or be able to formulate it according to NCI and FDA specifications. ACRIN PET scanner qualification is required as well as ACRIN qualification of the well counter calibration and of the MRI scanner. In addition, sites must identify an oncologist (neuro, medical, or radiation therapy) who agrees to support the identification and consenting of trial participants. Site Requirements: Contact project manager Bernadine Dunning ([email protected]); 215574-3228) or visit www.acrin.org/6684_protocol.aspx More Information: Experimental Imaging Sciences Committee Trial in Collaboration with the Breast Committee ACRIN 6688: Phase II Study of 3'-Deoxy-3'-18F Fluorothymidine (FLT) in Invasive Breast Cancer To evaluate the relationship between [18F]FLT uptake parameters and pathologic complete response to neoadjuvant therapy of the primary tumor in participants with locally advanced breast cancer. Primary Objective: Site Requirements: Participating sites will accrue 49 women into the ACRIN 6688 trial for which the protocol is currently in revision. Once approved, protocol amendment five will be posted to the ACRIN Web site. ACRIN PET qualification is required and sites must be located within the delivery region of the radio pharmacy producing the FLT agent or be able to formulate it according to NCI and FDA specifications. In addition, sites must identify an oncologist who agrees to support the identification and consenting of trial participants. Contact project manager Heather Polley ([email protected] ; 215-5743245) or visit www.acrin.org/TabID/597/Default.aspx . More Information: Experimental Imaging Sciences Committee Trial in Collaboration with the Abdominal Committee A Phase 2, Multicenter Evaluation of 18F-Fluoride PET as a Pharmacodynamic Biomarker for Dasatinib in Men With Castration-Resistant Prostate Cancer and Bone Metastases) ACRIN 6687: To determine whether changes in regional fluoride incorporation, measured by 18F-fluoride PET (SUV and Ki), will occur in both castration-resistant prostate cancer bone metastases and normal bone as a response to treatment with dasatinib. Primary Objective: The imaging protocol will be implemented at six pre-selected sites that are already participating in the companion therapeutic protocol sponsored by the Department of Defense and Bristol-Meyers Squibb. The imaging study, supported by the National Cancer Institute and coordinated by ACRIN, will accrue 24 participants with castration-resistant prostate cancer bone metastases. Site Requirements: More Information: Contact project manager Donna Hartfeil 2765) or visit www.acrin.org/6687_protocol.aspx . ([email protected]); 215-717-