Optical Tomography in Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Diffuse Optical Tomography (DOT) System

• Registration Number: NCT03215992
• Lead Sponsor: Columbia University

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).

Study Timeline

• Study Start: 2016-06-13
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Primary Completion: 2018-02-08
• Study Completion: 2018-02-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Men diagnosed with prostate cancer	Diffuse Optical Tomography (DOT) System	This group will include men over the age of 18 suspected of having prostate cancer who will undergo an ultrasound guided transrectal prostate biopsy. Each study participant will undergo a standard prostate biopsy and DOT imaging using the Diffuse Optical Tomography (DOT) System will be performed at the same time.
Men without prostate cancer	Diffuse Optical Tomography (DOT) System	This group will include men who do not have prostate cancer. Each study participant will undergo a standard prostate biopsy and DOT imaging using the Diffuse Optical Tomography (DOT) System will be performed at the same time.

Primary Outcome Measures

Name	Time	Method
Total number of subjects who are imaged using DOT and produce usable images	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States