Back to resultsThyroid Cancer and Photoacoustic Imaging
Primary Purpose
Thyroid Cancer, Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Photoacoustic imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Cancer focused on measuring Thyroid cancer, Photoacoustic imaging
Eligibility Criteria
Inclusion Criteria:
- All thyroid nodule identified as benign or as thyroid cancer
Exclusion Criteria:
- Patient refuses to participate in the study or withdraws consent
Sites / Locations
- Seoul St. Mary's hospitalRecruiting
Outcomes
Primary Outcome Measures
Photoacoustic analysis of thyroid nodule and thyroid cancer
Photoacoustic intensity of each chromophore (deoxyhemoglobin, oxyhemoglobin, lipid, water) obtained from ROI (region of interest) of photoacoustic image
Secondary Outcome Measures
Full Information
NCT ID
NCT04248166
First Posted
January 28, 2020
Last Updated
January 28, 2020
Sponsor
Seoul St. Mary's Hospital
Collaborators
Pohang University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04248166
Brief Title
Thyroid Cancer and Photoacoustic Imaging
Official Title
Diagnosis of Thyroid Cancer Using Photoacoustic Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
Pohang University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the usefulness of photoacoustic imaging in thyroid nodules. In addition, we would like to confirm the relationship between the results of photoacoustic imaging and histopathologic findings when thyroid nodules were diagnosed as thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroid Nodule
Keywords
Thyroid cancer, Photoacoustic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Photoacoustic imaging
Intervention Description
Photoacoustic image of thyroid nodule is obtained by using probe of photoacoustic imaging equipment and image data and data are stored in the device.
The patient's examination is the same as the general ultrasound, and the patient is asked to hold his breath for about 3-4 seconds to get the photoacoustic image.
Primary Outcome Measure Information:
Title
Photoacoustic analysis of thyroid nodule and thyroid cancer
Description
Photoacoustic intensity of each chromophore (deoxyhemoglobin, oxyhemoglobin, lipid, water) obtained from ROI (region of interest) of photoacoustic image
Time Frame
As soon as the photoacoustic test was performed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All thyroid nodule identified as benign or as thyroid cancer
Exclusion Criteria:
Patient refuses to participate in the study or withdraws consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeonghoon Ha, M.D.
Phone
82-2-2258-6372
Email
hajhoon@catholic.ac.kr
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeonghoon Ha, M.D
Phone
82-2-2258-6372
Email
hajhoon@catholic.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Thyroid Cancer and Photoacoustic Imaging
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