Cancer, Thyroid Clinical Trial
Official title:
Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05783323 -
Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06458036 -
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
|
Phase 2 |