B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in Thyroid Nodules

September 1, 2023 updated by: Salma Ahmed Ragheb, Assiut University

Comparative Study of B-mode Ultrasound, Sono-Elastography, and Diffusion-weighted Imaging MRI in the Characterization of Thyroid Nodules

To compare the accuracy of the conventional Ultrasound 'TI-RADS', US elastography, DWI MRI, and its ADC value in characterization and differentiation of thyroid nodules.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid nodules are one of the most common endocrine carcinomata (1) Most thyroid tumors have a good prognosis if early diagnosis and timely treated (2) An Ultrasound (US) exam is a safe, non-invasive imaging technique for detecting thyroid nodules (3) However, still there are no dependable criteria to discriminate malignant from benign lesions. (4) In 2009, Horvath et al proposed the Thyroid Imaging Report and Data System (TI-RADS). The new version of TI-RADS was launched by ACR in 2017. (5) Color Doppler ultrasound is also used to differentiate benign from malignant thyroid nodules. The presence of intra-nodular vascularity (Type 1b) was considered close to be malignant (6) US elastography is a novel tool to increase the diagnostic value of Ultrasound and as an adjuvant tool (7) Shear wave elastography evaluates elasticity through the propagation speed of shear waves, with the wave speed being faster in hard tissue (8) Conventional T1-and T2-weighted MR imaging can-not differentiate benign from malignant nodules (9) Diffusion-weighted imaging (DWI) is a non-invasive tool used to distinguish benign from malignant nodules (10). Malignant thyroid nodules usually have a lower ADC value attributed to cellular density and tissue perfusion. (11) Combining subjective MRI features with a quantitative measurement could improve the diagnostic yield of DW-MRI (12) The cytological examination by fine-needle aspiration (FNA) has become a reliable tool to diagnose thyroid cancers (2) Suspicious cytological findings reach up to 30% of all aspirated nodules, suggesting the need for less invasive methods (13)

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study will include patients referred to the radiology department at Assuit university presented with clinically thyroid-related neck swelling

Description

Inclusion Criteria:

  • Patients should have a normal bleeding profile.
  • Presence of solitary or multiple nodules in the thyroid gland.
  • In the case of patients having multiple nodules, the nodule having suspicious ultrasound features (having TI-RADS score 4 or 5) was selected for further analysis.
  • The nodules were either solid or mixed (containing both solid and cystic parts) with a predominant solid component

Exclusion Criteria:

  • Contraindicated biopsy (as thrombocytopenia or bleeding disorder).
  • Patient with cystic and mainly cystic nodules (TI-RADS 1 nodules).
  • Nodules with complete shell-calcification which may cause color mapping artifacts.
  • MRI contraindications such as Claustrophobia, MR-incompatible pacemakers, and MR-incompatible prosthetic heart valves.
  • Patients with recurrent thyroid masses.
  • History of operative procedure, chemo, or radiotherapy on the thyroid gland.
  • Declined consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)
Time Frame: 1 year
To assess concordance of US suspicious features, US elastography results , MRI DWI, ADC value results, and the gold standard US-guided FNAB and ability to differentiate benign from malignant thyroid nodules.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules
Time Frame: 1 year
compare ADC value of benign and malignant nodules to obtain a cutoff level
1 year
Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.
Time Frame: 1 year

compare also benign and malignant nodules qualitative and quantitative elastography results.

qualitative measurement is defined as :each nodule was assigned an elasticity score based on the color pattern type according to the classification proposed by Ueno classification method (color coded map) ranging from blue to green colors. hard nodules on the map appears as blue color and soft nodules appears as red color.

Quantitative assessment of the velocity of US wave propagation through tissue. measurement units are: kilopascal (Kpa), and shear wave velocity (m/sec).
1 year
Compare individual specific US features with the Gold standard US-guided FNAB which is more important.
Time Frame: 1 year

which is the most suspicious feature in ulrasound.

The five Ultrasound suspicious features are:

  1. predominantly Solid nodule.
  2. Marked hypoechogenicity.
  3. Microlobulated or irregular margins.
  4. Micro-Calcifications.
  5. Taller-than-wide in shape with a ratio ≥ 1.
1 year
Study role of color doppler in differentiating benign from malignant thyroid nodules
Time Frame: 1 year

which pattern of color doppler study is the most suspicious:

Classified into 4 groups:

0= Avascular.

1a= Peri-nodular vascularity.

1b= Intra-nodular vascularity.

1c= Peri-nodular and intranodular vascularity.
1 year
Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules
Time Frame: 1 year
combination of different imaging modalities which will have the best sensitivity and specificity for diagnosis of malignant thyroid nodules
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: noha mohamed ali, assistant professor, nohamohamedali@yahoo.com
  • Study Director: sami Abdel_Aziz Khalil, professor, samyKhalil24@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Elastography and DWI thyroid

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.

Clinical Trials on Thyroid Nodule

Clinical Trials on elastography, ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe