MR Imaging of Prostatic Calcifications

NCT03625336 | Withdrawn

• 1 other identifier: VR52257
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Calcification

Keywords

prostate; calcification; MRI

Outcome Measures

Primary Outcomes (1)

• Size of calcifications

  Size of calcifications including volume on CT compared to each of the 3 MRI sequences

  1 day At time of CT or MRI

Secondary Outcomes (1)

• Number of calcifications

  1 day At time of CT or MRI

Study Arms (1)

Prostate Calcifications

Men with prostate calcifications

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

An MRI will be obtained utilizing 3 different MRI sequences

Prostate Calcifications

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient has to have a prostate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men who are 18 years or older with prostatic calcifications on CT

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Related Publications (7)

• Zhu WZ, Qi JP, Zhan CJ, Shu HG, Zhang L, Wang CY, Xia LM, Hu JW, Feng DY. Magnetic resonance susceptibility weighted imaging in detecting intracranial calcification and hemorrhage. Chin Med J (Engl). 2008 Oct 20;121(20):2021-5.

  PMID: 19080268 BACKGROUND

• Tyler DJ, Robson MD, Henkelman RM, Young IR, Bydder GM. Magnetic resonance imaging with ultrashort TE (UTE) PULSE sequences: technical considerations. J Magn Reson Imaging. 2007 Feb;25(2):279-89. doi: 10.1002/jmri.20851.

  PMID: 17260388 BACKGROUND

• Straub S, Laun FB, Emmerich J, Jobke B, Hauswald H, Katayama S, Herfarth K, Schlemmer HP, Ladd ME, Ziener CH, Bonekamp D, Rothke MC. Potential of quantitative susceptibility mapping for detection of prostatic calcifications. J Magn Reson Imaging. 2017 Mar;45(3):889-898. doi: 10.1002/jmri.25385. Epub 2016 Jul 15.

  PMID: 27418017 BACKGROUND

• Bai Y, Wang MY, Han YH, Dou SW, Lin Q, Guo Y, Li W, Ding DG, Dai JP, Qin W, Shi DP, Tian J, Dai YM. Susceptibility weighted imaging: a new tool in the diagnosis of prostate cancer and detection of prostatic calcification. PLoS One. 2013;8(1):e53237. doi: 10.1371/journal.pone.0053237. Epub 2013 Jan 7.

  PMID: 23308170 BACKGROUND

• Adams LC, Boker SM, Bender YY, Diederichs G, Fallenberg EM, Wagner M, Hamm B, Makowski MR. Diagnostic accuracy of susceptibility-weighted magnetic resonance imaging for the evaluation of pineal gland calcification. PLoS One. 2017 Mar 9;12(3):e0172764. doi: 10.1371/journal.pone.0172764. eCollection 2017.

  PMID: 28278291 BACKGROUND

• Sundaram KM, Chang SS, Penson DF, Arora S. Therapeutic Ultrasound and Prostate Cancer. Semin Intervent Radiol. 2017 Jun;34(2):187-200. doi: 10.1055/s-0037-1602710. Epub 2017 Jun 1.

  PMID: 28579687 BACKGROUND

• Hong CG, Yoon BI, Choe HS, Ha US, Sohn DW, Cho YH. The Prevalence and Characteristic Differences in Prostatic Calcification between Health Promotion Center and Urology Department Outpatients. Korean J Urol. 2012 May;53(5):330-4. doi: 10.4111/kju.2012.53.5.330. Epub 2012 May 18.

  PMID: 22670192 BACKGROUND

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Janesh Lakhoo, MD

  Resident at Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiology Resident

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share