Clinical trial NCT01766869: Improving Cancer Foci Detection in Prostate Cancer Using Multiparametric MRI/MRS
Official title: Improving Cancer Foci Detection in Prostate Cancer Using Multiparametric MRI/MRS and Machine Learning to Better Manage the Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Prostate Cancer
MRI/MRS
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prostate cancer patients that have elected to go for radical prostatectomy

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Objective: distinguishing high-grade tumors vs. low-grade tumors and normal prostate
timeFrame: 16 months
Secondary outcomes:
measure: Secondary Objective: non-invasive and quantitative test to accurately identify the tumor grade and location.
timeFrame: 16 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ummc Msgcc
state: Maryland
Study officials:
affiliation: UMD
name: Warren D'Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References: