In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules

Thyroid Nodule Clinical Trial

— THYNODE  

Official title:

In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730726
• Other study ID #: 201900301
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2021
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thyroid nodules are common in clinical practice. Head and neck ultrasound is recommended as a routine examination for all patients with thyroid lesions. The Thyroid Imaging Reporting And Documentation System (TIRADS) criteria helps to estimate the risk of malignancy based on ultrasound patterns and nodule sizes guiding the performance of fine-needle-aspiration (FNA). Approximately 20% of FNA results cannot be specified whether being benign or malig-nant tissue. A definitive diagnosis can only be made from histopathology after diagnostic (hemi)thyroidectomy. However, (hemi)thyroidectomy has disadvantages as it leads to over-treatment and has a risk of postoperative morbidity (e.g. hypothyroidism and laryngeal nerve injury). Furthermore, (hemi)thyroidectomy is known to be associated with poor quality of life. Clearly, there is an unmet need for additional diagnostic tools in order to identify malignant thyroid nodules and thereby support the decision making for treatment of the thyroid.

Multispectral optoacoustic tomography (MSOT) is an innovative, non-invasive imaging method currently available in the UMCG that enables visualization of endogenous chromophores and exogenous contrast agents using the generation of ultrasound waves due to light absorption by using high frequency pulsed laser light. Recently, this system has been used by other groups for non-invasive determination of thyroid nodules. Results show that multispectral optoacoustic imaging of thyroid nodules may distinguish benign from malignant nodules. However, most certainly, a larger cohort is necessary to confirm this finding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with thyroid nodules who underwent or will undergo an ultrasonography (with TIRADS score) with FNA if indicated and will be scheduled for a (hemi)thyroidectomy if indicated;

2. Age = 18 years;

3. Written informed consent.

Exclusion Criteria:

1. Medical or psychiatric conditions that compromise the patients' ability to give informed consent;

2. Previous surgery in head and neck area

3. Previous radiotherapy in head and neck area

4. Pregnancy

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• MSOT Acuity Echo
Hybrid optoacoustic and ultrasonography imaging

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSOT signals of endogenous biomarkers	HbO2, HbR, HbT, sO2, fat, water and collagen	2 years
Secondary	Potential correlation FNA	To explore a potential correlation between endogenous optoacoustic signals in vivo with cytology (the standard-of-care of Bethesda scoring system derived from FNA)	2 years
Secondary	Potential correlation ultrasound	To explore a potential correlation between endogenous optoacoustic signals in vivo with TIRADS ultrasonography scoring system (the scoring system used by radiologists when evaluating the thyroid nodules with ultrasonography).	2 years