Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Thyroid Nodule

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Participants in this group will receive all three imaging techniques

Participants in this group will receive two imaging techniques

All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.

Ultrasound

Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called "pushing" and "tracking". First, in the "pushing" mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the "tracking" mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young's modulus, these data reveal information about the stiffness of underlying biological tissue.

Shear wave elasticity imaging

The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.

Multi-angle compound shear wave elasticity imaging

Stanislav Emelianov, PhD

In this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. During their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. The results of the SWEI scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.

Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. In many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be performed on the same ultrasound equipment and within the same imaging session. Therefore, integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. Other studies have demonstrated the ability of SWEI techniques to differentiate benign from malignant thyroid nodules. However, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. These techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. The researchers believe that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To this end, this study will perform proof-of-concept studies of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology.

Study participants will undergo a single SWEI session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard SWEI, and ultrasound, or only standard SWEI and ultrasound.

Thyroid Ultrasound Elasticity (TrUE) Imaging

Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules

As part of the pre-operative visit, participants will have imaging of their thyroid nodules. Established SWEI and MAC-SWEI techniques will be performed to identify malignant thyroid tissue.

Tissue samples obtained during the participant's thyroid biopsy, thyroidectomy, or cervical node biopsy will be submitted to the pathology lab as part of the clinical standard of care. The pathology report will specify whether or not malignant cells were found in the tissue sample.

The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.

Emory University

Adjunct Professor

Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.

Patients will receive 131I therapy after 6 months of larotrectinib. Larotrectinib will be continued for 5 days after RAI therapy and then patients will enter a wait and see period off treatment.

Patients who experience disease progression at any point while on larotrectinib will proceed to 131I therapy and discontinue larotrectinib.

Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.

Larotrectinib monotherapy

Patients will receive 131I therapy after 6 months of larotrectinib.

131I therapy

Supriya Behl

James Robinson

Theodore Laetsch, MD

Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.

This is an open label, non-randomized study to evaluate the efficacy and safety of the combination of larotrectinib followed by 131I therapy for patients with NTRK fusion differentiated thyroid cancer. The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of larotrectinib given for 6-months followed by 131I therapy.

This will be an open label, non-randomized study to evaluate the efficacy and safety of the combination of larotrectinib followed by 131I therapy for patients with NTRK fusion differentiated thyroid cancer.

Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

Larotrectinib to Enhance RAI Avidity in Patients With Differentiated Thyroid Cancer Harboring NTRK Fusions

The primary endpoint is the complete pulmonary structural response rate to larotrectinib by modified Nies et al thyroid cancer response criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Thyroid Ultrasound Elasticity (TrUE) Imaging	NCT03307694	Cancer, Thyroid	Ultrasound Shear wave elas... Multi-angle com...	18 Years -	Emory University
Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer	NCT05783323	Differentiated ... Pediatric Cance... Cancer Cancer, Thyroid	Larotrectinib m... 131I therapy	2 Years - 99 Years	Children's Hospital of Philadelphia

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