In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules (THYNODE)
Primary Purpose
Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MSOT Acuity Echo
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with thyroid nodules
Arm Description
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
Outcomes
Primary Outcome Measures
MSOT signals of endogenous biomarkers
HbO2, HbR, HbT, sO2, fat, water and collagen
Secondary Outcome Measures
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)
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).
Full Information
NCT ID
NCT04730726
First Posted
January 26, 2021
Last Updated
January 26, 2021
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT04730726
Brief Title
In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
Acronym
THYNODE
Official Title
In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with thyroid nodules
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MSOT Acuity Echo
Intervention Description
Hybrid optoacoustic and ultrasonography imaging
Primary Outcome Measure Information:
Title
MSOT signals of endogenous biomarkers
Description
HbO2, HbR, HbT, sO2, fat, water and collagen
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Potential correlation FNA
Description
To explore a potential correlation between endogenous optoacoustic signals in vivo with cytology (the standard-of-care of Bethesda scoring system derived from FNA)
Time Frame
2 years
Title
Potential correlation ultrasound
Description
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).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schelto Kruijff, MD, PhD
Phone
0031503612317
Email
s.kruijff@umcg.nl
First Name & Middle Initial & Last Name & Degree
Schelto Kruijff, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules
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