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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102099
Recruitment Status : Unknown
Verified March 2017 by Ying Fu, Peking University Third Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ying Fu, Peking University Third Hospital

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

Condition or disease Intervention/treatment
Thyroid Nodules Procedure: contrast-enhanced ultrasound group Procedure: conventional ultrasound group

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Application Value of Contrast-enhanced Ultrasound-guided Fine-needle Aspiration Biopsy in the Evaluation of Thyroid Nodules
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who intends to perform fine needle aspiration (FNA) at the Peking University Third hospital.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102099


Locations
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China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Ying Fu, Ph.D Peking University Third Hospital
Principal Investigator: Li-Gang Cui, M.D. Peking University Third Hospital
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Responsible Party: Ying Fu, Principal Investigator, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03102099    
Other Study ID Numbers: PekingUTH_001
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms