We aim to determine if in vivo MSOT can distinguish benign from malignant thyroid nodules by correlating and validating optoacoustic signals in vivo with pathology results.
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is quantification of the optoacoustic signal (HbO2,
HbR, HbT, sO2, fat, water and collagen) observed by multispectral optoacoustic
imaging using the MSOT Acuity Echo in vivo in patients with thyroid nodules,
also in relation to the definitive pathology results (benign vs malignant).
Secondary outcome
- To explore a potential correlation between endogenous optoacoustic signals in
vivo with cytology (the standard-of-care of Bethesda scoring system derived
from FNA)
- 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).
Background 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 ma-lignant 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 a novel non-invasive imaging
method that enables visualization of endogenous chromophores and exogenous
contrast agents using the generation of ultrasound waves due to light
absorption. Recently, this system has been used for non-invasive determination
of thyroid nodules. Results show that multispectral optoacoustic imaging of
thyroid nodules may distinguish benign from malignant nodules. However, a
larger cohort is necessary to confirm this finding.
Study objective
We aim to determine if in vivo MSOT can distinguish benign from malignant
thyroid nodules by correlating and validating optoacoustic signals in vivo with
pathology results.
Study design
The current study is a non-randomized, non-blinded, single center, prospective,
cross-sectional, proof of concept study.
Intervention
Included patients will undergo MSOT imaging of the thyroid nodules.
Study burden and risks
A potential risk of MSOT is cornea damage when looking straight into the laser.
As everyone present in the MSOT room during imaging is obligated to wear laser
safety goggles, this risk is covered. In addition, there is an interlock system
in the room so that no one else can enter the room when the imaging system is
activated.
The risk associated with the use of MSOT seems minor and although patients will
not directly benefit from this study, results of this study will provide
valuable information for our understanding of the diagnostic value of MSOT in
distinguising benign from malignant thyroid nodules.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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 on the ipsilateral side of the index
nodule
3. Previous radiotherapy in head and neck area
4. Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69993.042.19 |