Hyperspectral Imaging for Neoplasm Early Stage Detection (HINED)

March 24, 2018 updated by: Dong-Ru Ho, Chang Gung Memorial Hospital

Utilize Hyperspectral Imaging to Reveal the Possible Clues of Neoplasm for Early Stage Detection

Background Information With the advance in cancer biology, we realize that malignant neoplasm is related with different biological patterns in metabolome and microbiota. Because of the progress in optical spectrometry, it has become possible to evaluate whole visible and innon-visiable absorptive spectrum in human specimens, which may enable detection of minor changes in compound related with altered metabolome and microbiota. We hope to utilize hyperspectral imagingthis spectrum technology to reveal the possible clues of neoplasm for early stage detection

Material and Methods This research intended to enroll one hundred patients into the study. This includes patients with positive stool or urine analysis admitted for workup of colorectal cancer. We will scan the stool and urine with hyperspectral imaging sensoroptical spectrometer, which utilize multichannel charge-coupled device and InGaAs array to analyze the full spectrum of light patterns. The image pattern will be stored and used to linked final diagnosis. Absorption, scattering, and reflection spectra are expected for analysis. Follow up analysis after cancer staging will be used for lowering background noise in all spectra.

Expected Results We expect that there will be specific spectral pattern in stool of colorectal cancer patients, which may be related with cancer staging and different from those in patients without malignancy. Difference in spectra will lead to discovery of new biomarker for colorectal cancer and related diseases. The optic spectra pattern of stool and urine may assist early diagnosis and staging of different malignancies

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background Information With the advance in cancer biology, we realize that malignant neoplasm is related with different biological patterns in metabolome and microbiota. Because of the progress in optical spectrometry, it has become possible to evaluate whole visible and innon-visiable absorptive spectrum in human specimens, which may enable detection of minor changes in compound related with altered metabolome and microbiota. We hope to utilize hyperspectral imagingthis spectrum technology to reveal the possible clues of neoplasm for early stage detection

Material and Methods This research intended to enroll one hundred patients into the study. This includes patients with positive stool or urine analysis admitted for workup of colorectal cancer. We will scan the stool and urine with hyperspectral imaging sensoroptical spectrometer, which utilize multichannel charge-coupled device and InGaAs array to analyze the full spectrum of light patterns. The image pattern will be stored and used to linked final diagnosis. Absorption, scattering, and reflection spectra are expected for analysis. Follow up analysis after cancer staging will be used for lowering background noise in all spectra.

Expected Results We expect that there will be specific spectral pattern in stool of colorectal cancer patients, which may be related with cancer staging and different from those in patients without malignancy. Difference in spectra will lead to discovery of new biomarker for colorectal cancer and related diseases. The optic spectra pattern of stool and urine may assist early diagnosis and staging of different malignancies

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 613
        • Recruiting
        • Dong-Ru Ho
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with positive stool or urine analysis who are above 20 year-old

Description

Inclusion Criteria:

  • patients with positive stool or urine analysis
  • above 20 year-old
  • previous stool or urine analysis negative 8 weeks ago

Exclusion Criteria:

  • pregnancy
  • active gastrointestinal disease one year ago
  • active infection
  • having surgery within a year
  • underlying active gastrointestinal, urinary tract, and coagulation disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neoplasm
neoplasm found in follow up
Diagnostic test: hyperspectral imaging
using hyperspectral detector for evaluation excreta pattern
non-neoplasm
non-neoplasm patients in follow up
Diagnostic test: hyperspectral imaging
using hyperspectral detector for evaluation excreta pattern

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neoplasm diagnosis
Time Frame: 6 months after examination
pathology diagnosis in examination
6 months after examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

September 30, 2018

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

March 24, 2018

First Posted (ACTUAL)

March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701068B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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