Improving Cancer Foci Detection in Prostate Cancer Using Multiparametric MRI/MRS

NCT ID: NCT01766869

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-04-30

Brief Summary

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The investigators' goal is to develop a non-selective and non-invasive procedure to identify aggressive tumors and simultaneously identify their exact location in Prostate cancer patients undergoing radical prostatectomy by combining multiparametric MRI and machine learning techniques. The combination of multi-parametric MRI and machine learning (validated using histopathology) can lead to increased sensitivity and specificity of cancer foci in the prostate, and help in isolating aggressive from indolent tumors. This increased sensitivity and specificity may eventually lead to: a) a reduction in the number of patients that undergo unnecessary treatment, and b) enhance current treatment options by enabling the use of focused therapies. The investigators will recruit 15 patients with prostate cancer that are currently scheduled to undergo radical prostatectomy into the study. All patients will obtain an advanced MRI study prior to the radical prostatectomy. MRI scans will include a) high-resolution volumetric images using T1 and T2-weighted imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. Following radical prostatectomy, a pathologist will grade the prostatectomy specimens based on standard of care (Gleason grading system). Correlations will be generated between the parameters obtained from scans and from clinical assessments.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. All male patients that have opted for radical prostatectomy
2. Subjects must be capable of giving informed consent.
3. Subjects must not be claustrophobic.

Exclusion Criteria

1. Subjects with pacemakers.
2. Subjects who have metallic ferromagnetic implants or pumps.
3. All females are excluded from this study.
4. Subjects with kidney disease of any severity or on hemodialysis.
5. Subjects with known allergies to gadolinium-based contrast agents.
6. Subjects incapable of lying on their backs for up to an hour at a time.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Department of Radiation Oncology

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Warren D'Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

UMD

Locations

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Ummc Msgcc

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00054431

Identifier Type: -

Identifier Source: org_study_id

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