Optical Tomography in Prostate Cancer

NCT03215992 | Completed DMC FDA Device

• 1 other identifier: AAAL3709
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Diffuse Optical Tomography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Men diagnosed with prostate cancer

OTHER

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

Men without prostate cancer

OTHER

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

Interventions

Diffuse Optical Tomography (DOT) System DEVICE

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.

Men diagnosed with prostate cancer; Men without prostate cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication for magnetic resonance imaging

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Emerson Lim, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 12, 2017
• Study Start: June 13, 2016
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

US (1)