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In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules

NCT ID: NCT04730726

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MSOT Acuity Echo

Intervention Type DEVICE

Hybrid optoacoustic and ultrasonography imaging

Interventions

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MSOT Acuity Echo

Hybrid optoacoustic and ultrasonography imaging

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Schelto Kruijff, MD PhD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Schelto Kruijff, MD, PhD

Role: primary

Other Identifiers

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201900301

Identifier Type: -

Identifier Source: org_study_id