Optical Tomography in Prostate Cancer

Columbia University

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Diffuse Optical Tomography (DOT) System

Study type: Interventional

Funder types: Other

Identifiers

NCT03215992

AAAL3709

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Men diagnosed with prostate cancer

Other group

Description:

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.

Treatment:

Device: Diffuse Optical Tomography (DOT) System

Men without prostate cancer

Other group

Description:

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.

Treatment:

Device: Diffuse Optical Tomography (DOT) System