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Optical Tomography in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215992
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Emerson Lim, 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Diffuse Optical Tomography (DOT) System Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Diffuse Optical Tomography in Prostate Cancer Detection and Risk Stratification A Pilot Study
Actual Study Start Date : June 13, 2016
Actual Primary Completion Date : February 8, 2018
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Men diagnosed with prostate cancer
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
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 without prostate cancer
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
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.




Primary Outcome Measures :
  1. Total number of subjects who are imaged using DOT and produce usable images [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215992


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Emerson Lim, MD Columbia University

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Responsible Party: Emerson Lim, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03215992     History of Changes
Other Study ID Numbers: AAAL3709
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Emerson Lim, Columbia University:
Diffuse Optical Tomography
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases