Hyperspectral Imaging for Neoplasm Early Stage Detection

NCT03483974 | Unknown

• 1 other identifier: 201701068B0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperspectral Imaging Data of Excreta

Keywords

Hyperspectrum, excreta, neoplasm,

Outcome Measures

Primary Outcomes (1)

• neoplasm diagnosis

  pathology diagnosis in examination

  6 months after examination

Study Arms (2)

neoplasm

neoplasm found in follow up

Diagnostic Test: hyperspectral imaging

non-neoplasm

non-neoplasm patients in follow up

Diagnostic Test: hyperspectral imaging

Interventions

hyperspectral imaging DIAGNOSTIC_TEST

using hyperspectral detector for evaluation excreta pattern

neoplasm; non-neoplasm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Dong-Ru Ho

Chiayi City, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Chih-Shou Chen

CONTACT

+886975353211; cgmh5093@gmail.com

DONG-RU HO

CONTACT

+14158573127; redoxdrh@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: March 30, 2018
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: September 30, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)