Prostate CancerNCT01653093
3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
A study testing 3-Tesla magnetic resonance imaging (3T MRI), diffusion-weighted magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging in people with Prostate Cancer, run by University of Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3-Tesla magnetic resonance imaging (3T MRI), diffusion-weighted magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2007to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center, Stress
Columbus, Ohio, 43210
About this study
Official title: 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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Prostate Cancer
- Being tested
- 3-Tesla magnetic resonance imaging (3T MRI), diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging, magnetic resonance spectroscopic imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Tesla magnetic resonance imaging (3T MRI)Procedure or surgery
Also called 3-Tesla MRI, 3T MRI
Undergo 3T MRI
diffusion-weighted magnetic resonance imagingProcedure or surgery
Also called diffusion-weighted MRI
Undergo diffusion-weighted MRI
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Undergo DCE-MRI
magnetic resonance spectroscopic imagingProcedure or surgery
Also called 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (3T MRI) | Experimental | Patients undergo 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. Receives: Procedure: 3-Tesla magnetic resonance imaging (3T MRI); Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
The primary outcome in this study is the agreement in tumor staging between pathology and 3 Tesla MRI.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study start20 Sep 2007
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael Knopp, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653093
- Sponsor's protocol ID
- OSU-07042
- Other IDs
- NCI-2012-00931
- Status last verified
- Apr 2025
- First submitted
- 26 Jul 2012
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of the Prostate Gland Using High Field Strength 3T MRI
- ClinicalTrials.gov ID
- NCT01653093
- Acronym / sponsor ID
- OSU-07042
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 20 Sep 2007 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (3T MRI) | Experimental | Procedure: 3-Tesla magnetic resonance imaging (3T MRI), Procedure: diffusion-weighted magnetic resonance imaging, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: magnetic resonance spectroscopic imagingPatients undergo 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Tesla magnetic resonance imaging (3T MRI)Also: 3-Tesla MRI, 3T MRIUndergo 3T MRI | Procedure or surgery | Diagnostic (3T MRI) |
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRIUndergo diffusion-weighted MRI | Procedure or surgery | Diagnostic (3T MRI) |
| dynamic contrast-enhanced magnetic resonance imagingAlso: DCE-MRIUndergo DCE-MRI | Procedure or surgery | Diagnostic (3T MRI) |
| magnetic resonance spectroscopic imagingAlso: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic ImagingUndergo MR spectroscopy | Procedure or surgery | Diagnostic (3T MRI) |
Primary outcome
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil
Time frame: Up to 6 years
The primary outcome in this study is the agreement in tumor staging between pathology and 3 Tesla MRI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Knopp, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Tesla magnetic resonance imaging (3T MRI), diffusion-weighted magnetic resonance imaging and dynamic contrast-enhanced magnetic resonance imaging in people with Prostate Cancer, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.