In-vivo multispectral optoacoustic imaging of thyroid nodules
Completed
- Conditions
- thyroid nodulesthyroid tumor10014713
- Registration Number
- NL-OMON49819
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is quantification of the optoacoustic signal (HbO2,<br /><br>HbR, HbT, sO2, fat, water and collagen) observed by multispectral optoacoustic<br /><br>imaging using the MSOT Acuity Echo in vivo in patients with thyroid nodules,<br /><br>also in relation to the definitive pathology results (benign vs malignant).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To explore a potential correlation between endogenous optoacoustic signals in<br /><br>vivo with cytology (the standard-of-care of Bethesda scoring system derived<br /><br>from FNA)<br /><br>- To explore a potential correlation between endogenous optoacoustic signals in<br /><br>vivo with TIRADS ultrasonography scoring system (the scoring system used by<br /><br>radiologists when evaluating the thyroid nodules with ultrasonography). </p><br>