Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules
Application Value of Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules
1 other identifier
observational
400
1 country
1
Brief Summary
To evaluate the application value of contrast-enhanced ultrasound in the diagnosis of thyroid nodules using fine needle aspiration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 10, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedApril 5, 2017
March 1, 2017
1.4 years
March 10, 2017
March 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The Bethesda System for Reporting Thyroid Cytology (TBSRTC)
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
Study Arms (2)
contrast-enhanced ultrasound group
The contrast-enhanced ultrasound(CEUS)patients will undergo biopsy with contrast-enhanced ultrasound guidance.
conventional ultrasound group
The conventional ultrasound group will undergo biopsy with conventional ultrasound guidance.
Interventions
The contrast-enhanced ultrasound patients will undergo biopsy with contrast-enhanced ultrasound guidance.
The conventional ultrasound group will undergo biopsy with conventional ultrasound guidance.
Eligibility Criteria
Patients who intends to perform fine needle aspiration (FNA) at the Peking University Third hospital.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Fu, Ph.D
Peking University Third Hospital
- PRINCIPAL INVESTIGATOR
Li-Gang Cui, M.D.
Peking University Third Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2017
First Posted
April 5, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2019
Last Updated
April 5, 2017
Record last verified: 2017-03