NCT05734326

Brief Summary

Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

March 3, 2022

Last Update Submit

February 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy.

    Patients will be scanned with SWE The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer.

    Base line

Interventions

ultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA \[18\].

Also known as: FNAC

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be scanned with SWE, The thyroid gland carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer. The shape, size, margin and echo-pattern of the lesions will be determined.then compared with FNAC results as the correct needle position inside the nodule and then in aspiration which, Finally elasticity scores and strain ratio calculations will be compared with FNAC results.

You may qualify if:

  • all patients referred to radiology department presented clinically with solitary thyroid nodule .

You may not qualify if:

  • patients previously underwent thyroid surgery
  • patients with severe uncorrectable bleeding diathesis.
  • Patients refused to sign consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fresilli D, David E, Pacini P, Del Gaudio G, Dolcetti V, Lucarelli GT, Di Leo N, Bellini MI, D'Andrea V, Sorrenti S, Mascagni D, Biffoni M, Durante C, Grani G, De Vincentis G, Cantisani V. Thyroid Nodule Characterization: How to Assess the Malignancy Risk. Update of the Literature. Diagnostics (Basel). 2021 Jul 30;11(8):1374. doi: 10.3390/diagnostics11081374.

    PMID: 34441308BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Mohamed Gabeer, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mariam Mosad, Master Degree

CONTACT

Ahmed Mostafa, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiology professor Ahmed mostafa

Study Record Dates

First Submitted

March 3, 2022

First Posted

February 17, 2023

Study Start

May 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 17, 2023

Record last verified: 2023-02