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MR Imaging of Prostatic Calcifications

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625336
Recruitment Status : Withdrawn (study on hold for an undetermined time)
First Posted : August 10, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janesh Lakhoo, Vanderbilt University Medical Center

Brief Summary:
Prostate calcifications can limit evaluation of the prostate due to artifact on MRI, and can limit therapy by blocking therapeutic ultrasound. There is definite need to develop and validate MR imaging techniques to visualize focal calcifications, especially for focal therapy planning and monitoring. It will obviate need for CT correlation, help in focal ablation modality selection and give true relative location of the calcification vis-à-vis visualized tumor without need for fusion. Imaging calcifications and evaluation of their effect on high energy ultrasound will help us define clinically significant calcifications. It is also the first step in development of techniques to mitigate effect of calcifications on therapeutic ultrasound. Multiple promising MR sequences are available for possible evaluation of the prostate and this study looks to evaluate the ability of those MRI sequences at detecting and accurately quantifying prostatic calcifications compared to CT, the current gold standard.

Condition or disease Intervention/treatment
Prostate Calcification Diagnostic Test: MRI

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MR Imaging of Prostatic Calcifications
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prostate Calcifications
Men with prostate calcifications
Diagnostic Test: MRI
An MRI will be obtained utilizing 3 different MRI sequences




Primary Outcome Measures :
  1. Size of calcifications [ Time Frame: 1 day At time of CT or MRI ]
    Size of calcifications including volume on CT compared to each of the 3 MRI sequences


Secondary Outcome Measures :
  1. Number of calcifications [ Time Frame: 1 day At time of CT or MRI ]
    Number of prostate calcifications seen on CT and on MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient has to have a prostate.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Men who are 18 years or older with prostatic calcifications on CT
Criteria

Inclusion Criteria:

  • Men 18 years and older
  • prostate calcifications on CT obtained within the last 6 months

Exclusion Criteria:

  • subjects with known prostate cancer
  • subjects with any type of bioimplant, mechanical, electronic or magnetic means because such devices may be displaced or malfunction
  • patients with cerebral aneurysm clips
  • patient's with embedded shrapnel, metal workers, and machinists
  • subjects who cannot adhere to the experimental protocols
  • subjects who are not able to give consent
  • subjects who exhibit claustrophobia or who exhibit severe vertigo when moved into the magnet.
  • prisoners
  • any other reason not included above, that would preclude the patient from obtaining an MRI

Information from the National Library of Medicine

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): NCT03625336


Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Janesh Lakhoo, MD Resident at Vanderbilt University Medical Center
Publications:

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Responsible Party: Janesh Lakhoo, Radiology Resident, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03625336    
Other Study ID Numbers: VR52257
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janesh Lakhoo, Vanderbilt University Medical Center:
prostate
calcification
MRI
Additional relevant MeSH terms:
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Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases