3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01653093|
Recruitment Status : Recruiting
First Posted : July 30, 2012
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: 3-Tesla magnetic resonance imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging||Not Applicable|
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).
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Imaging of the Prostate Gland Using High Field Strength 3T MRI|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||July 3, 2018|
|Estimated Study Completion Date :||July 3, 2018|
Experimental: Diagnostic (3T MRI)
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.
Procedure: 3-Tesla magnetic resonance imaging
Undergo 3T MRI
Procedure: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRI
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRI
Procedure: magnetic resonance spectroscopic imaging
Undergo MR spectroscopy
- Diagnostic imaging quality of the prostate at 3T high field imaging without an endorectal coil [ Time Frame: Up to 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653093
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|Contact: Michael Knopp, MDfirstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University Medical Center, Stress||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Michael V. Knopp 614-293-9998 email@example.com|
|Principal Investigator: Michael V. Knopp|
|Principal Investigator:||Michael Knopp, MD||Ohio State University|