Skip to main content
Clinical Trials/NCT03215992
NCT03215992
Completed
Not Applicable

Diffuse Optical Tomography in Prostate Cancer Detection and Risk Stratification A Pilot Study

Columbia University1 site in 1 country9 target enrollmentJune 13, 2016
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Columbia University
Enrollment
9
Locations
1
Primary Endpoint
Total number of subjects who are imaged using DOT and produce usable images
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study is looking to see if a new device, diffuse optical tomography (DOT), can detect prostate cancer. The investigators will also see if DOT can tell the difference between high risk and low risk prostate cancers.

Detailed Description

While some of these tools have helped to guide therapy in patients with prostate cancer, they are imperfect and as a result many men undergo unnecessary treatment for a disease that would not have caused their deaths. An improved method to risk stratify men with prostate cancer prior to definitive therapy may reduce the over-treatment rate, while maintaining or improving mortality. Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. DOT analyzes the light being reflected and transmitted through tissue to generate three-dimensional images of chromophores and light scattering. As such, DOT serves as a functional imaging modality, measuring both tissue vascularity and architecture. The investigators believe that DOT will be able to detect prostate cancer in men suspected of the disease and will also be able to risk-stratify patients found to have prostate cancer to help guide treatment options. DOT may be able to directly measure two factors important in the prognosis of patients with prostate cancer: the Gleason score and microvessel density (MVD).

Registry
clinicaltrials.gov
Start Date
June 13, 2016
End Date
February 8, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emerson Lim

Assistant Professor of Medicine

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Men 18 years of age or older scheduled for transrectal prostate biopsy or radical prostatectomy at Columbia University Medical Center
  • Signing consent for study imaging procedure and analysis of prostate biopsy
  • Exclusion criteria:
  • Patients failing to meet the inclusion criteria
  • Contraindication for magnetic resonance imaging

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Total number of subjects who are imaged using DOT and produce usable images

Time Frame: Up to 3 years

Total number of subjects who produce usable images will be measured to assess feasibility of concurrent transrectal ultrasound guided (TRUS) biopsy/DOT imaging, which is defined as successfully imaging and generating usable DOT data in 60% of subjects.

Study Sites (1)

Loading locations...

Similar Trials