3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/23/2019 |
| Start Date: | September 2007 |
| End Date: | December 31, 2020 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCClinicaltrials@osumc.edu |
| Phone: | 1-800-293-5066 |
Imaging of the Prostate Gland Using High Field Strength 3T MRI
In standard clinical care, the prostate is imaged by magnetic resonance imaging (MRI) which
is a procedure to take pictures of body structures by using a strong magnetic field and radio
waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla
number means the magnet has stronger pull. Standard magnetic resonance imaging of the
prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna)
inserted into the body due to the limitations using an external body coil at this magnet
strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of
creating a signal twice as strong that can be received by the antennas, resulting in better
pictures. The goal of this study is to make the MRI procedure more comfortable for patients
by using an external coil instead of an endorectal coil. With this study, researchers also
want to help patients' health care teams, the surgeons in particular. Researchers will assess
the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external
body coil on helping doctors decide which approaches to disease therapy might be best for
patients as well as correlate patients' study images with all other clinical imaging
is a procedure to take pictures of body structures by using a strong magnetic field and radio
waves. The strength of the magnet used is expressed in the unit Tesla (T); a higher Tesla
number means the magnet has stronger pull. Standard magnetic resonance imaging of the
prostate uses a magnet 1.5 Tesla strong as well as a specialized endorectal coil (antenna)
inserted into the body due to the limitations using an external body coil at this magnet
strength. MRI using a 3 Tesla magnet has a theoretical advantage over imaging at 1.5 Tesla of
creating a signal twice as strong that can be received by the antennas, resulting in better
pictures. The goal of this study is to make the MRI procedure more comfortable for patients
by using an external coil instead of an endorectal coil. With this study, researchers also
want to help patients' health care teams, the surgeons in particular. Researchers will assess
the impact of prostate MRI, without an endorectal coil, done at 3 Tesla and with an external
body coil on helping doctors decide which approaches to disease therapy might be best for
patients as well as correlate patients' study images with all other clinical imaging
PRIMARY OBJECTIVES:
I. To assess the impact of prostate MRI, without an endorectal coil, done at 3-Tesla on
surgical management. This would be performed by examining the agreement of lesion location
based on the MRI compared to the lesion location based on pathology and/or surgery and local
extent of the disease, i.e. involvement of contiguous organs and local lymph nodes, based on
the MRI compared to the local extent based on pathology and/or surgery.
II. To test the reproducibility of functional MRI (dynamic-contrast enhanced [DCE_MRI] MRI,
magnetic resonance [MR] spectroscopy and diffusion-weighted MRI).
SECONDARY OBJECTIVES:
I. To assess the usefulness of MRI data in treatment planning for radiation therapy, and to
test the feasibility of amide-proton-transfer MRI in prostate cancer detection.
II. To evaluate MRI changes in prostate and tumor morphology between endorectal coil versus
no endorectal coil.
III. To assess the usefulness of ex-vivo prostate specimen MRI for accurate co-registration
between in-vivo MRI of the prostate and pathology slides.
OUTLINE:
Patients undergo 3-tesla (3T) MRI, including DCE-MRI, diffusion-weighted MRI,
amide-proton-transfer MRI, and MR spectroscopy scans. Patients may undergo an additional 3T
MRI scan at least 24 hours after the initial scan.
I. To assess the impact of prostate MRI, without an endorectal coil, done at 3-Tesla on
surgical management. This would be performed by examining the agreement of lesion location
based on the MRI compared to the lesion location based on pathology and/or surgery and local
extent of the disease, i.e. involvement of contiguous organs and local lymph nodes, based on
the MRI compared to the local extent based on pathology and/or surgery.
II. To test the reproducibility of functional MRI (dynamic-contrast enhanced [DCE_MRI] MRI,
magnetic resonance [MR] spectroscopy and diffusion-weighted MRI).
SECONDARY OBJECTIVES:
I. To assess the usefulness of MRI data in treatment planning for radiation therapy, and to
test the feasibility of amide-proton-transfer MRI in prostate cancer detection.
II. To evaluate MRI changes in prostate and tumor morphology between endorectal coil versus
no endorectal coil.
III. To assess the usefulness of ex-vivo prostate specimen MRI for accurate co-registration
between in-vivo MRI of the prostate and pathology slides.
OUTLINE:
Patients undergo 3-tesla (3T) MRI, including DCE-MRI, diffusion-weighted MRI,
amide-proton-transfer MRI, and MR spectroscopy scans. Patients may undergo an additional 3T
MRI scan at least 24 hours after the initial scan.
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 prostate-specific antigen [PSA] of > 10ng/dl) will be
referred from the outpatient clinics after evaluation by the treating physicians
- Written informed consent will be signed by the patients before the MRI based on the
guidelines approved by the Ohio State University Institutional Review board
- Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2
within six weeks of the MRI to be included in the study
Exclusion Criteria:
- Patients with any type of bioimplant activated by mechanical, electronic, or magnetic
means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators,
electronic infusion pumps, etc.)
- Patients with any type of ferromagnetic bioimplant that could potentially be displaced
or damaged
- Patients that have vascular or aneurysm clips, or metallic staples from a surgical
procedure
- Patients with permanent tattoo eye liner (may contain metallic coloring)
- Patients 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
- Patients that exhibit noticeable anxiety and/or claustrophobia
- Patients who cannot adhere to the experimental protocols for any reason, or have an
inability to communicate with the researcher
- Patients who have cardiac or known circulatory impairment, and/or the inability to
perspire (poor thermoregulatory function)
- Patients with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within
six weeks of the MRI
- Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30
mL/min/1.73m^2)
- 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 43210
Principal Investigator: Michael V. Knopp
Phone: 614-293-9998
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