In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules

NCT04730726 | Unknown

• 1 other identifier: 201900301
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• MSOT signals of endogenous biomarkers

  HbO2, HbR, HbT, sO2, fat, water and collagen

  2 years

Secondary Outcomes (2)

• Potential correlation FNA

  2 years

• Potential correlation ultrasound

  2 years

Study Arms (1)

Patients with thyroid nodules

EXPERIMENTAL

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

Interventions

MSOT Acuity Echo DEVICE

Hybrid optoacoustic and ultrasonography imaging

Patients with thyroid nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Age ≥ 18 years;
• Written informed consent.

You may not qualify if:

• Medical or psychiatric conditions that compromise the patients' ability to give informed consent;
• Previous surgery in head and neck area
• Previous radiotherapy in head and neck area
• Pregnancy

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

NL (1)