NCT04248166

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 28, 2020

Last Update Submit

January 28, 2020

Conditions

Thyroid CancerThyroid Nodule

Keywords

Thyroid cancerPhotoacoustic imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    As soon as the photoacoustic test was performed

Interventions

Photoacoustic imagingDEVICE

1. Photoacoustic image of thyroid nodule is obtained by using probe of photoacoustic imaging equipment and image data and data are stored in the device. 2. 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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All thyroid nodule identified as benign or as thyroid cancer

You may not qualify if:

  • Patient refuses to participate in the study or withdraws consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Jeonghoon Ha, M.D.

CONTACT

82-2-2258-6372hajhoon@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

KR(1)