Assessment of Amide-Proton-Transfer MRI in Prostate Cancer
The goal of this trial is to evaluate the capability of the amide-proton-transfer magnetic
resonance imaging (APT-MRI) technique for detection and characterization of prostate cancer.
Prostate cancer typically shows a high tumor cell proliferation rate and cellular density
that leads to overall elevated mobile protein and peptide levels. An imaging method that can
non-invasively measure these mobile protein levels may considerably improve our ability to
better regionally localize prostate cancer and predict the degree of malignancies. APT-MRI
has recently emerged as a new molecular MRI technique to measure endogenous cellular mobile
protein and peptide levels non-invasively, which cannot otherwise be provided by current
prostate imaging techniques [Zhou J, Tryggestad E, Wen Z, et al. Differentiation between
glioma and radiation necrosis using molecular magnetic resonance imaging of endogenous
proteins and peptides. Nat Med 2011; 17:130-134]. The preliminary data from 12 prostate
cancer patients reveals that the increased APT-MRI signal of mobile proteins and peptides in
cancerous regions of the prostate and in higher stage tumors [Jia G, Abaza R, Williams JD,
et al. Amide proton transfer MR imaging of prostate cancer: a preliminary study. J Magn
Reson Imaging 2011; 33:647-654], indicates that the APT-MRI signal is sensitive to the
elevated mobile protein and peptide levels in such malignant regions. These initial
observations are the basis for a rigorous validation trial.
The trial is be implemented within a well-established ongoing collaboration at the James
Cancer Hospital and Solove Research Institute (NCI-designated CCC) at the Ohio State
University Medical Center. Patients with biopsy-proven prostate cancer will be referred and
enrolled by urologists performing robotic prostatectomy. A comprehensive imaging scan
including APT-MRI will be implemented by radiologists, MR physicists and technologists with
a phased array surface coil in order to image the prostate in its natural shape. Our
protocol will include micro-MRI of the prostate specimen prior to pathologic evaluation
using an ultra-high-field MRI scanner. The prostate specimen will subsequently be cut in a
way that allows direct correlation of the specimen to micro-MRI. A dedicated pathology team
will delineate the extent of malignant infiltration in the prostate on pathologic slides,
which will be co-registered with the clinical and APT-MRI images to allow a targeted
assessment with a radiologic-pathologic correlation. The data analysis will be done by the
study team and the statistics evaluated by an experienced biostatistician in the subject
matter at hand.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of the APT-MRI signal in different prostatic zones
Pathology analysis. Region of Interest (ROI) will be placed on digitized pathologic slides by two experienced uro-pathologists. APTR of the ROIs will be used to evaluate the difference of mobile protein and peptide levels by co-registering digitized pathologic slides with APT-MRI. Radiology Read. The APT-MRI signal maps of mobile proteins and peptides will be color-coded and reviewed by two experienced radiologists. Tumor location and local extent will be recorded based on conventional MRI without and with the APT-MRI signal maps.
up to 2 years
No
Michael V Knopp, MD PhD
Study Director
Ohio State University
United States: Institutional Review Board
2007C0048/OSU-07042
NCT01705028
September 2007
June 2014
Name | Location |
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Martha Morehouse Medical Plaza - Wright Center of Innovation in Biomedical Imaging | Columbus, Ohio 43221 |