Optical Tomography in Prostate Cancer

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Diffuse Optical Tomography (DOT) System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Men diagnosed with prostate cancer<br>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. | Device: Diffuse Optical Tomography (DOT) System<br>* 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.<br>|
| Other: Men without prostate cancer<br>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. | Device: Diffuse Optical Tomography (DOT) System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse Optical Tomography