Clinical Research Directory

Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial

The investigators hypothesize that all-cause mortality in patients with an incidental thyroid nodule on PET-CT who did not have thyroid ultrasound (the exposure) within 3 months of the PET-CT is non-inferior within a 5% margin to those who have thyroid ultrasound at 7-years. That is, among patients with an incidental thyroid nodule on PET-CT, mortality is no more than 5% larger (in absolute difference) for those who do not have thyroid ultrasound compared to those who do. The investigators will also report mortality differences at landmark timeframes of 1-year, 3-years, 5-years, and 10-years. To estimate group differences in mortality, the investigators will conduct a non-inferiority emulated target trial utilizing clone-censor weighting to address potential immortal time bias introduced by the 3-month grace period. The investigators will adjust for demographic, potential confounder, and mortality risk adjustor factors. The investigators will stratify analyses based on baseline disease severity (estimated 5-year relative survival risk) and disease status (progression, lymph node involvement, other sites of metastases). All subjects will be accrued from the Mass General Brigham healthcare system, which includes two academic medical centers, a specialty head and neck hospital, and multiple community hospitals and numerous community clinics.

Safety & Feasibility of Ultrasound-assisted Non-invasive Measurement of Compressibility of the Thyroid Gland in Patients Scheduled for Surgical Removal

The thyroid gland plays an important role in hormone regulation however, it is often prone to nodules. This is common with nodules being found in up to 68% of people in a neck ultrasound, with likelihood increasing with age. However, only about 1 in 20 nodules turns out to be cancerous. Diagnosis of thyroid nodules starts with ultrasonic assessment, where specific features have been identified to estimate the risk of malignancy. If further examination is recommended, Fine Needle Aspiration (FNA) is performed. A needle is inserted into the nodule and the obtained subset of cells are then classified into 6 categories (Bethesda score) after examination under the microscope. While some Bethesda scores provide very accurate malignancy predictions, others like category 4, are unspecific, with risk of malignancy ranging from 25 to 40%. For these patients, about 75% are operated on even though they are not prospectively diagnosed. Soft tissue has certain physical properties, including its compressibility, which could be quantified by measuring the pressure required to deform it. It has been found that cancerous tissue is often harder than the surrounding healthy tissue. Compremium, a Swiss company which has its headquarters in Muri bei Bern, has developed a device that can be used to measure the compressibility of tissue, similarly to palpation but providing a quantitative assessment. The present study aims to investigate the feasibility and preliminary efficacy of this new technology to predict if thyroid nodules of patients scheduled for surgical removal based on FNA analysis are malignant or not.

Investigation of the Effect of Using "Curtain"

Thyroid nodules are among the common health problems in adulthood. Thyroid cancers account for approximately 1% of all malignancies in a year.The majority of cancers are diagnosed by thyroid fine needle aspiration biopsy. The most commonly diagnosed cancer type is papillary thyroid cancer and accounts for 85% of all thyroid cancers.Thyroid Ultrasonography is the most important imaging method used in the evaluation of the thyroid gland and its nodules. It enables the detection of nodules and their characteristics and plays a role in deciding which nodules should be evaluated with fine needle aspiration biopsy.Non-pharmacological treatment methods are interventions that can be used to reduce the side effects of medical, surgical or pharmacological treatments. By using medical treatment and complementary therapy together, nurses can reduce patients' anxiety, support their sleep, create a healing environment and increase their health level. As a non-pharmacological strategy, distraction can be seen as a cost-effective approach to reduce anxiety in procedures that would cause negative anxiety and increase the opportunity for ease of operation. The curtain method also typically involves the use of visually interesting curtains or partitions that can be drawn around the patient's examination area. These curtains may have calming images or vibrant patterns that can help shift the patient's focus away from the frightening procedure being performed.

The Effect of Virtual Reality Applications

Thyroid nodules are a common health problem in the adult population. The majority of cancers are diagnosed by thyroid fine needle aspiration biopsy. Thyroid nodules generally show clinical findings in 1-5% of cases on physical examination and 20-70% on ultrasound examination. In diagnosis; Ultrasonography, fine needle aspiration biopsy, ultrasonography-guided fine needle aspiration biopsy, scintigraphy, computed tomography and magnetic resonance imaging are widely used. The fact that the thyroid fine needle aspiration biopsy procedure is painful, there is no speaking or coughing during the procedure, and in case of insufficient sample, the procedure must be performed several times. Its repetition causes fear and anxiety in patients. A combination of pharmacological and nonpharmacological methods for pain control likely provides the most effective pain relief for the patient. Distraction is one of the non-pharmacological methods used in pain control. Distraction is one of the most preferred methods to reduce pain in patients during diagnosis and treatment procedures. It is a method that allows patients to control and reduce the symptoms they experience by focusing their attention on a different point.The aim of this study is to examine the effect of using a motivational video with virtual reality glasses to distract attention during the biopsy procedure on pain, stress and fear in individuals with suspected thyroid cancer.

Thyroid Nodule Gene Sequencing in a Danish Population

This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population. Patients with thyroid nodules suspected of malignancy is included prospectively. Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.