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Thyroid NoduleNCT06029946

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

An observational study of Thyroid Nodule, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Thyroid Nodule
What is being tested?
elastography, ultrasound
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2023to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

salma ahmed ragheb, assistant lecturer contact

01025656052

salmarageb3456@gmail.com

Mona Gouda Maghrabi, lecturer contact

01062307637

Mona.gouda@medicine.luxor.edu.eg

About this study

Official title: 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.

Read the 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)

Conditions
Thyroid Nodule
Being tested
elastography, ultrasound
Keywords
Elastography, DWI thyroid, Thyroid Ultrasound
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elastography, ultrasoundDiagnostic test

    Also called MRI and fine needle biopsy

    First local anesthesia with lidocaine 2%, then 3 smears will be obtained for each nodule using a 20-22 gauge needle, multiple passes within the lesion will be made to obtain sufficient cells, the aspirate will be spread over a glass, fixed with ethanol 95% and submitted to the pathology department to be reported.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results)

    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.

    Measured: 1 year

Secondary outcomes (5)

  1. Apply ADC value Cut-off level to differentiate benign from malignant thyroid nodules

    compare ADC value of benign and malignant nodules to obtain a cutoff level

    Measured: 1 year

  2. Apply US shear elastography parameters Cut-off levels to differentiate benign from malignant thyroid nodules.

    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).

    Measured: 1 year

  3. Compare individual specific US features with the Gold standard US-guided FNAB which is more important.

    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.

    Measured: 1 year

  4. Study role of color doppler in differentiating benign from malignant thyroid nodules

    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.

    Measured: 1 year

  5. Compare the added value of combining different modalities, which have the higher sensitivity and specificity in differentiating benign from malignant thyroid nodules

    combination of different imaging modalities which will have the best sensitivity and specificity for diagnosis of malignant thyroid nodules

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029946
Sponsor's protocol ID
Elastography and DWI thyroid
Status last verified
Sep 2023
First submitted
23 Jan 2023
Last updated
8 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qin P, Wu K, Hu Y, Zeng J, Chai X. Diagnosis of Benign and Malignant Thyroid Nodules Using Combined Conventional Ultrasound and Ultrasound Elasticity Imaging. IEEE J Biomed Health Inform. 2020 Apr;24(4):1028-1036. doi: 10.1109/JBHI.2019.2950994. Epub 2019 Nov 4.

    PubMed 31689223

  • Wu Q, Li Y, Liu Y, Shen J, Wang Y, Yi X, Hu B. The value of conventional sonography and ultrasound elastography in decision-making for thyroid nodules in different categories of the Bethesda system for reporting thyroid cytopathology. Clin Hemorheol Microcirc. 2020;74(3):255-266. doi: 10.3233/CH-180533.

    PubMed 31683465

  • Floridi C, Cellina M, Buccimazza G, Arrichiello A, Sacrini A, Arrigoni F, Pompili G, Barile A, Carrafiello G. Ultrasound imaging classifications of thyroid nodules for malignancy risk stratification and clinical management: state of the art. Gland Surg. 2019 Sep;8(Suppl 3):S233-S244. doi: 10.21037/gs.2019.07.01.

    PubMed 31559190

  • Zhang WB, Li JJ, Chen XY, He BL, Shen RH, Liu H, Chen J, He XF. SWE combined with ACR TI-RADS categories for malignancy risk stratification of thyroid nodules with indeterminate FNA cytology. Clin Hemorheol Microcirc. 2020;76(3):381-390. doi: 10.3233/CH-200893.

    PubMed 32675401

  • Swan KZ, Bonnema SJ, Jespersen ML, Nielsen VE. Reappraisal of shear wave elastography as a diagnostic tool for identifying thyroid carcinoma. Endocr Connect. 2019 Aug;8(8):1195-1205. doi: 10.1530/EC-19-0324.

    PubMed 31340198

  • Kwak JY, Kim EK. Ultrasound elastography for thyroid nodules: recent advances. Ultrasonography. 2014 Apr;33(2):75-82. doi: 10.14366/usg.13025. Epub 2014 Feb 26.

    PubMed 24936499

  • Wang H, Wei R, Liu W, Chen Y, Song B. Diagnostic efficacy of multiple MRI parameters in differentiating benign vs. malignant thyroid nodules. BMC Med Imaging. 2018 Dec 3;18(1):50. doi: 10.1186/s12880-018-0294-0.

    PubMed 30509198

  • Gorgulu FF. Which Is the Best Reference Tissue for Strain Elastography in Predicting Malignancy in Thyroid Nodules, the Sternocleidomastoid Muscle or the Thyroid Parenchyma? J Ultrasound Med. 2019 Nov;38(11):3053-3064. doi: 10.1002/jum.15013. Epub 2019 Apr 29.

    PubMed 31037753

  • Cantisani V, David E, Grazhdani H, Rubini A, Radzina M, Dietrich CF, Durante C, Lamartina L, Grani G, Valeria A, Bosco D, Di Gioia C, Frattaroli FM, D'Andrea V, De Vito C, Fresilli D, D'Ambrosio F, Giacomelli L, Catalano C. Prospective Evaluation of Semiquantitative Strain Ratio and Quantitative 2D Ultrasound Shear Wave Elastography (SWE) in Association with TIRADS Classification for Thyroid Nodule Characterization. Ultraschall Med. 2019 Aug;40(4):495-503. doi: 10.1055/a-0853-1821. Epub 2019 May 28.

    PubMed 31137050

  • Aghaghazvini L, Maheronnaghsh R, Soltani A, Rouzrokh P, Chavoshi M. Diagnostic value of shear wave sonoelastography in differentiation of benign from malignant thyroid nodules. Eur J Radiol. 2020 May;126:108926. doi: 10.1016/j.ejrad.2020.108926. Epub 2020 Mar 3.

    PubMed 32171916

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Nodule, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact salma ahmed ragheb, assistant lecturer (01025656052, salmarageb3456@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

compare findings of ultrasound, elastography values , ADC value with the gold standard (biopsy results) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029946, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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