3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer
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|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
Other Names:Procedure: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRIProcedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRIProcedure: 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 ]
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|