In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules (THYNODE)

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: MSOT Acuity Echo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Schelto Kruijff, MD, PhD; Phone Number: 0031503612317; Email: s.kruijff@umcg.nl
    • Principal Investigator: Schelto Kruijff, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with thyroid nodules; Patients with thyroid nodules that underwent or will undergo an ultrasound with FNA if indicated and if indicated will be scheduled for a (hemi)thyroidectomy	Device: MSOT Acuity Echo; Hybrid optoacoustic and ultrasonography imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSOT signals of endogenous biomarkers	HbO2, HbR, HbT, sO2, fat, water and collagen	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: 201900301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No