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Assessment of Amide-Proton-Transfer MRI in Prostate Cancer

Phase 0
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients with known or suspected prostate disease based on clinical data will be
included in the study.

- Patients with intermediate to high grade prostate cancer (Gleason's score >/=7 and
PSA of >10ng/dl) will be referred from the outpatient clinics after evaluation by the
treating physicians.

- Male

- Patients must have an estimated Glomerular Filtration Rate of ≥ 30 mL/min/1.73m2
within six weeks of the MRI to be included in the study.

Exclusion Criteria:

- Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic
means (e.g., cochlear implants, pacemakers, neurostimulators

- Subjects with any type of ferromagnetic bioimplant that could potentially be
displaced or damaged.

- Subjects that have vascular or aneurysm clips, or metallic staples from a surgical

- Subjects with permanent tattoo eye liner (may contain metallic coloring).

- Subjects that may have shrapnel imbedded in their bodies, such as from war wounds,
metal workers and machinists (metallic fragments in or near eyes), severe auto
accident victims.

- Subjects that exhibit noticeable anxiety and/or claustrophobia.

- Subjects who cannot adhere to the experimental protocols for any reason, or have an
inability to communicate with the researcher.

- Subjects who have cardiac or known circulatory impairment, and/or the inability to
perspire (poor thermoregulatory function).

- Subjects with an estimated Glomerular Filtration Rate of < 30 mL/min/1.73m2 within
six weeks of the MRI.

- Acute or chronic severe renal insufficiency (estimated Glomerular Filtration

- Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative
liver transplantation period

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of the APT-MRI signal in different prostatic zones

Outcome Description:

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.

Outcome Time Frame:

up to 2 years

Safety Issue:


Principal Investigator

Michael V Knopp, MD PhD

Investigator Role:

Study Director

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

June 2014

Related Keywords:

  • Prostate Cancer
  • Tesla MRI
  • Prostate cancer
  • Amide proton transfer MRI
  • chemical exchange
  • Saturation transfer
  • Mobile protein level
  • Molecular imaging
  • Prostatic Neoplasms



Martha Morehouse Medical Plaza - Wright Center of Innovation in Biomedical Imaging Columbus, Ohio  43221