Malignant Thyroid Gland NeoplasmNCT03174925
Ultrasound Elastography in Imaging Patients With Thyroid Nodules
A study testing Siemens Acuson S3000 ultrasound system in people with Malignant Thyroid Gland Neoplasm and Thyroid Gland Nodule, run by Stanford University at 1 site in United States.
Trial summary
This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule
- What is being tested?
- Siemens Acuson S3000 ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2014to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration
Who cannot join
- Patients who are unable to lie supine for a biopsy
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: Elastography in Thyroid Nodule Evaluation
This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.
Read the detailed description
PRIMARY OBJECTIVES:
Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer.
Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively "tissue stiffness," and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules.
Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.
- Being tested
- Siemens Acuson S3000 ultrasound system
- 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.
Siemens Acuson S3000 ultrasound systemDevice
Shear Wave Elastography
| Study group | Role | What they receive |
|---|---|---|
| Tissue Stiffness by Elastography | Experimental | Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. Receives: Device: Siemens Acuson S3000 ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness of Thyroid Nodules as Measured by Elastography
Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start24 Jan 2014
- Primary completion13 Feb 2018
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Thyroid Gland NeoplasmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Model description
- Siemens Acuson S3000 ultrasound system
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Kamaya, Stanford University
- Investigators
- Aya Kamaya, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174925
- Sponsor's protocol ID
- IRB-23634
- Other IDs
- NCI-2017-00841, END0020
- Status last verified
- Jun 2021
- First submitted
- 18 May 2017
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastography in Thyroid Nodule Evaluation
- ClinicalTrials.gov ID
- NCT03174925
- Acronym / sponsor ID
- IRB-23634
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Jan 2014 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.
Detailed description
PRIMARY OBJECTIVES:
Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer.
Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively "tissue stiffness," and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules.
Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Siemens Acuson S3000 ultrasound system
| Arm | Type | Receives |
|---|---|---|
| Tissue Stiffness by Elastography | Experimental | Device: Siemens Acuson S3000 ultrasound systemPotentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration
Key exclusion criteria (2 listed)
- Patients who are unable to lie supine for a biopsy
- Pregnant patients
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 |
|---|---|---|
| Siemens Acuson S3000 ultrasound systemShear Wave Elastography | Device | Tissue Stiffness by Elastography |
Primary outcome
Stiffness of Thyroid Nodules as Measured by Elastography
Time frame: 1 week
Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Aya Kamaya principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Siemens Acuson S3000 ultrasound system in people with Malignant Thyroid Gland Neoplasm and Thyroid Gland Nodule, run by Stanford University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 8 Jul 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness of Thyroid Nodules as Measured by Elastography (time frame: 1 week). 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 8 Jul 2021.