Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207188
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2024-01-03
Brief Title:
Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters
Detailed Description:
PRIMARY OBJECTIVES
I Identification of thyroid nodules by vibro-acoustography - Determine detection rate
II Evaluate the specificity of VA in differentiating malignant and benign of thyroid nodules - Compare the result to that of ultrasound US
III Assess diagnostic value of Shear Wave Ultrasound Vibrometry SDUV and Comb Push shear elastography CUSE in differentiation of thyroid nodules - correlate SDUV and CUSE results to pathology
IV Test and compare the results shear wave imaging with new FDA approved ultrasound device called SuperSonic Imagine Aixplorer
V Assess diagnostic value of Shear Wave Ultrasound Vibrometry SDUV and Comb Push shear elastography CUSE in differentiation of palpable and sonographically detectable cervical lymph nodes or non-thyroidal neck masses
VI Assess the diagnostic values of ultrasound quantitative microvessel imaging for differentiation of thyroid nodules and cervical lymph nodes
VII Assess the response to alcohol ablation on patients with recurrent thyroid cancer on thyroid bed or new lymph nodes on neck
OUTLINE This is an observational study
Patients undergo ultrasound imaging on study
I Identification of thyroid nodules by vibro-acoustography - Determine detection rate
II Evaluate the specificity of VA in differentiating malignant and benign of thyroid nodules - Compare the result to that of ultrasound US
III Assess diagnostic value of Shear Wave Ultrasound Vibrometry SDUV and Comb Push shear elastography CUSE in differentiation of thyroid nodules - correlate SDUV and CUSE results to pathology
IV Test and compare the results shear wave imaging with new FDA approved ultrasound device called SuperSonic Imagine Aixplorer
V Assess diagnostic value of Shear Wave Ultrasound Vibrometry SDUV and Comb Push shear elastography CUSE in differentiation of palpable and sonographically detectable cervical lymph nodes or non-thyroidal neck masses
VI Assess the diagnostic values of ultrasound quantitative microvessel imaging for differentiation of thyroid nodules and cervical lymph nodes
VII Assess the response to alcohol ablation on patients with recurrent thyroid cancer on thyroid bed or new lymph nodes on neck
OUTLINE This is an observational study
Patients undergo ultrasound imaging on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA148994 | NIH | Mayo Clinic in Rochester | httpsreporternihgovquickSearchR01CA148994 |
| NCI-2023-10842 | REGISTRY | None | None |
| 08-008778 | OTHER | None | None |
| P30CA015083 | NIH | None | None |