Optical Tomography in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215992
• Other study ID #: AAAL3709
• Status: Completed
• Phase: N/A
• Start date: June 13, 2016
• Est. completion date: February 8, 2018

Study information

• Verified date: August 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Diffuse Optical Tomography (DOT) System
Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. As light of a specific wavelength travels through tissue, it is absorbed and scattered by different chromophores and cellular structures. Using four wavelengths of light allows the detection of four chromophores: oxyhemoglobin, deoxyhemoglobin, water and fat.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of subjects who are imaged using DOT and produce usable images	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.	Up to 3 years