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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-