Assessment of Amide-Proton-Transfer MRI in Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2016 |
| Start Date: | September 2007 |
| End Date: | June 2016 |
| Contact: | Guang Jia, PhD |
| Email: | jia.11@osu.edu |
| Phone: | 614-366-7937 |
Of cancer related deaths in American men, prostate cancer continues to be the second most
common cause. The limitations of prostate imaging technology affect its contribution to
clinical assessment and treatment management of prostate cancer. The high tumor cell
proliferation rate and cellular density of prostate cancer leads to overall elevated mobile
protein and peptide levels. The protein levels in the prostate can be non-invasively
detected by a new molecular imaging technique called amide-proton-transfer magnetic
resonance imaging (APT-MRI). APT-MRI will provide efficient measurement for improving our
ability to better regionally localize prostate cancer and predict tumor stages. The overall
goal of this trial is to evaluate the capability of the APT imaging technique for detection
and characterization of prostate cancer. APT-MRI could be an important quantitative marker
to better delineate and detect malignant regions of the prostate in the management of
prostate cancer patients.
common cause. The limitations of prostate imaging technology affect its contribution to
clinical assessment and treatment management of prostate cancer. The high tumor cell
proliferation rate and cellular density of prostate cancer leads to overall elevated mobile
protein and peptide levels. The protein levels in the prostate can be non-invasively
detected by a new molecular imaging technique called amide-proton-transfer magnetic
resonance imaging (APT-MRI). APT-MRI will provide efficient measurement for improving our
ability to better regionally localize prostate cancer and predict tumor stages. The overall
goal of this trial is to evaluate the capability of the APT imaging technique for detection
and characterization of prostate cancer. APT-MRI could be an important quantitative marker
to better delineate and detect malignant regions of the prostate in the management of
prostate cancer patients.
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.
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
procedure.
- 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
We found this trial at
1
site
Columbus, Ohio 43221
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