Thyroid CancerNCT04248166
Thyroid Cancer and Photoacoustic Imaging
A study testing Photoacoustic imaging in people with Thyroid Cancer and Thyroid Nodule, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- What is being tested?
- Photoacoustic imaging
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All thyroid nodule identified as benign or as thyroid cancer
Who cannot join
- Patient refuses to participate in the study or withdraws consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Jeonghoon Ha, M.D, 82-2-2258-6372, hajhoon@catholic.ac.kr
About this study
Official title: Diagnosis of Thyroid Cancer Using Photoacoustic Imaging
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.
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- Photoacoustic imaging
- Keywords
- Thyroid cancer, Photoacoustic imaging
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic imagingDevice
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: As soon as the photoacoustic test was performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pohang University of Science and Technology
- Responsible party
- Principal investigator, Dong Jun Lim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248166
- Sponsor's protocol ID
- KC15DISI0276
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Thyroid Cancer Using Photoacoustic Imaging
- ClinicalTrials.gov ID
- NCT04248166
- Acronym / sponsor ID
- KC15DISI0276
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Keywords
- Thyroid cancer, Photoacoustic imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Pohang University of Science and Technology
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All thyroid nodule identified as benign or as thyroid cancer
Key exclusion criteria (1 listed)
- Patient refuses to participate in the study or withdraws consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic imaging1. 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. | Device | – |
Primary outcome
Photoacoustic analysis of thyroid nodule and thyroid cancer
Time frame: As soon as the photoacoustic test was performed
Photoacoustic intensity of each chromophore (deoxyhemoglobin, oxyhemoglobin, lipid, water) obtained from ROI (region of interest) of photoacoustic image
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Thyroid Cancer
Enrolling by invitationObservational study
Head and Neck Cancer Strategies
Head and Neck Cancer (H&N), Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Radiofrequency Ablation Study in LatinX Patients
Thyroid Nodule
RecruitingPhase 2
Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery
Neoadjuvant Treatment, Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic imaging in people with Thyroid Cancer and Thyroid Nodule, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeonghoon Ha, M.D. (82-2-2258-6372, hajhoon@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoacoustic analysis of thyroid nodule and thyroid cancer (time frame: As soon as the photoacoustic test was performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.