Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules

March 29, 2017 updated by: Ying Fu, Peking University Third Hospital

Application Value of Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules

To evaluate the application value of contrast-enhanced ultrasound in the diagnosis of thyroid nodules using fine needle aspiration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Thyroid nodules and thyroid cancer are common and frequently occurring diseases in China; Relevant researches reveal that the increase in the incidence of thyroid cancer is more prominent in China than that of overseas, the incidence of thyroid cancer in urban residents of Beijing increased from 1.55/100,000 in 1995 to 9.9/100,000 in 2010 (5.38 fold).

The rapid development of imaging techniques including ultrasound, CT and MRI had substantially increased the accuracy in the diagnosis of thyroid nodules, however the accuracy is still not up to 100% and a further aspiration biopsy is required. Therefore, ultrasound-guided percutaneous biopsy plays a critical role in the diagnosis of pathological lesions. Many guidelines deem fine needle aspiration (FNA) biopsy to be the most accurate and cost-effective examination method in the evaluation of thyroid nodules as it helps to reduce unnecessary thyroid nodule surgeries and it also helps the clinicians to determine the appropriate surgical treatment plan[1-4]. However according to literature reports, samples with insufficient quantity of cells can occur up to 10-15% of the cases, sometimes a second biopsy or a diagnostic operation needs to be performed[1,4].False negative results of FNA biopsy or a mismatch between ultrasound diagnosis and clinical diagnosis can occur due to a number of reasons such as the tumor being too big or too small, a poor location, presence of degenerative necrosis, inappropriate position of biopsy or be affected by the operator's experience etc.

Contrast-enhanced ultrasound (CEUS) is a new technology which is recently introduced into China, it has the ability to display the microvascular perfusion of the tissue under a low mechanical index. The serial real-time images obtained can be digitalized and dynamically stored. And this allows for retrospective analysis and also enables comparison to be made with other imaging techniques. CEUS can sensitively reflect the characteristics of blood supply and microcirculation at the site of the lesion.

Although CEUS-guided FNA of thyroid nodules has not yet been reported, a large number of studies have reported liver biopsy performed under the guidance of CEUS. Its efficacy in obtaining accurate diagnosis and in reducing the number of biopsies is clear when samples are taken from the area of rich blood supply.

Metabolic-active areas within the malignant tumor, or areas of degeneration or necrosis and also the detection of small tumors can be confirmed through the use of CEUS. Aspiration biopsy when performed under the guidance of CEUS is expected to yield decreased non-diagnostic result. The investigators intent to create a randomized controlled study to investigate the application value of CEUS in the diagnosis of space-occupying lesions of the thyroid using FNA.

Data collection Collect and sort out the general data of patients, record the conventional US findings and the contrast-enhanced ultrasound (group CEUS) findings of the two groups, and also the results from aspiration biopsy and pathology, fill in the case report form (CRF), establish a database. Carry out analysis using specialized statistical software. Four parameters of efficacy (inadequacy, indeterminacy, malignancy, and benign) rates) were evaluated in the series of thyroid FNA and compared with the two groups. The inadequacy rate refers to the proportion of cases with a non-diagnostic result. The indeterminate rate refers to the proportion of cases with an atypia of undetermined significance/follicular lesion of undetermined significance (AUS or FLUS) category. The malignancy rate refers to the proportion of cases that were malignant. The benign rate refers to the proportion of cases that were benign. The number of obtained cells in the specimens with diagnostic result was classified into two classes according the cytopathologist's experience: intermediate (diagnosed possible), and abundant (diagnosed easily). The comparison of cell amount between the two groups is secondary aim.

Statistical analysis Statistical analysis is carried out using SPSS 22.0, all statistical data will be analyzed using the Chi square test. Differences were considered statistically significant at p<0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who intends to perform fine needle aspiration (FNA) at the Peking University Third hospital.

Description

Inclusion Criteria:

  • Patients with a space-occupying thyroid lesion found either via conventional ultrasound or CT/MRI and clinically requiring a further biopsy.
  • Age 18 years old or above with no limitation of gender.
  • Obtain a signed informed consent.

Exclusion Criteria:

  • Contraindications to the use of contrast agents as described by the medication guide.
  • Patients who are contraindicated to aspiration biopsy: patients with unexplained bleeding history, severe anemia, or patients who have a tendency to bleed and this bleeding disorder has not been corrected (prothrombin time 3-5seconds longer than the normal control, platelet count <60000/mm3); no safe aspiration path; menstruating female patients.
  • If the patient has a serious psychological or mental problem, and is suspected to have a poor compliance with the current clinical study, or maybe unable to obtain a definitive diagnosis for the lesion.
  • Pregnant or lactating women or women with a positive pregnancy test before their first medications are given.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
contrast-enhanced ultrasound group
The contrast-enhanced ultrasound(CEUS)patients will undergo biopsy with contrast-enhanced ultrasound guidance.
Procedure: contrast-enhanced ultrasound group
The contrast-enhanced ultrasound patients will undergo biopsy with contrast-enhanced ultrasound guidance.
conventional ultrasound group
The conventional ultrasound group will undergo biopsy with conventional ultrasound guidance.
Procedure: conventional ultrasound group
The conventional ultrasound group will undergo biopsy with conventional ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Bethesda System for Reporting Thyroid Cytology (TBSRTC)
Time Frame: From date of randomization until the date of first documented cytopathology result of fine needle aspiration (FNA) on the suspected nodule, assessed up to 1 month
To evaluate contrast-enhanced ultrasound (CEUS) improving the technical sufficiency of fine needle aspiration (FNA). The Bethesda System for Reporting Thyroid Cytology (TBSRTC) has six general diagnostic categories. Each of the categories has an implied cancer risk (ranging from 0 to 3% for the benign category to nearly 100% for the malignant category) with rational clinical management guidelines.
From date of randomization until the date of first documented cytopathology result of fine needle aspiration (FNA) on the suspected nodule, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ying Fu, Ph.D, Peking University Third Hospital
  • Principal Investigator: Li-Gang Cui, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PekingUTH_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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