Thyroid cancer Thyroid Nodules
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Written informed consent - Having a TI-RADAS 3-5 thyroid nodule identified via standard of care US for which US-guided FNA is indicated - Willing and able to complete all procedures and assessments in accordance with the clinical protocol
Exclusion criteria
Exclusion criteria: - Medical or psychiatric conditions that compromise the subject*s ability to give Informed Consent - A condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.) that could interfere with the intended Field of view (within one probe length or 4 cm of the nodule) - Thyroid nodule greater than 3.0 cm in maximum diameter - Previous or on-going radioactive iodine treatment - Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid - Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline - Are currently undergoing phototherapy - Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) - Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity - Subject has received chemotherapy for any type of cancer within 90 days from date of screening or standard of care Ultrasound - Previous surgery in head and neck area on the ipsilateral side of the index nodule - Previous radiotherapy in head and neck area - Subject is pregnant (asked during IC procedure) - Have had previous FNA of the target nodule of interest within the 45 days of baseline OA - Subject has participated in a clinical study of an investigational drug or device within 3 months prior to screening ultrasound imaging that may have an impact on clinical outcomes of this study - Subject has previously participated in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is an early feasibility study exploring the use of OA for thyroid nodule evaluation using HbR and HbO2 signal. Much is still unknown about the interpretation of the images in thyroid nodules,therefore, both qualitative and quantitative analysis will be performed as primary analysis: 1. Images and data will be reviewed first by Investigator Independent Reviewers (experienced radiologists) to provide a basis for determining feature score signals that indicate benign or malignant thyroid nodules as well as aggressive and non-aggressive cancers. 2. A comparison of the in vivo opto-acoustic features on imaging with those obtained from standard diagnostic imaging will also be done by the Investigator Independent Reviewers (experienced radiologists). 3. Once thyroid feature scores are developed, Physician Independent Readers (experienced radiologists) will read the images collected and score the nodules using the new thyroid feature scoring system to determine whether a nodule is considered benign or malignant. Descriptive statistics on the feature scores will be performed as part of the primary analysis. 4. Lymph Nodes will be assessed for pathology correlation with thyroid cancer histopathology and cytology The thyroid nodule will be marked with a region of interest (ROI) in the obtained OA images. The signal (HbR vs HbO2) will be qualitatively interpreted by three independent readers not involved in standard clinical practice (experienced radiologists), blinded for cytology/histopathology results. The index nodule will be classified as *not suspicious* or *suspicious* for malignancy. In addition, quantitative descriptive statistics will be performed. 5. The diagnostic accuracy of OA will be determined using cytology and histopathology as golden standard. As such, sensitivity (Se), Sp, positive predictive value (PPV), negative predictive value (NPV) and accuracy are calculated. 6. AEs will be summarized for the Safety population. The numb | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary analyses includes TI-RADs scores and OA/US thyroid nodule feature scores stratified by cytology and histopathology type. In addition to overall (i.e. pooled site data) analyses, summaries of each study endpoint and other clinical/demographic/safety data will be provided by study site in order to evaluate the consistency of the results across study sites as a secondary analysis. Additional analyses by clinical and/or demographic subgroups may be performed on the following characteristics: - Nodule Size - Nodule Depth - Age of Patient - Type of cancer Two-sided 95% confidence intervals will be calculated where appropriate. | — |
Countries
Netherlands
Outcome results
None listed