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NCT03106337 · ClinicalTrials.gov registry record · NA
Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid
A NA study of Thyroid Nodule and Follicular Neoplasm, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03106337: Completed NA study of Thyroid Nodule and Follicular Neoplasm, sponsored by Massachusetts General Hospital.
NCT03106337 is a NA study of Thyroid Nodule and Follicular Neoplasm that has completed, run by Massachusetts General Hospital. The registered enrollment target is 35 participants, below the 77-participant average among 5 other Thyroid Nodule trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03106337, a NA study of Thyroid Nodule and Follicular Neoplasm, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion. The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion. The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.
Primary Outcome
Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.
Conditions Studied
Interventions
- DEVICE Shear-Wave Elastography
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT03106337 record still lists
NCT03106337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 77-participant average among 5 other Thyroid Nodule trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Thyroid Nodule appearing as the primary indexed condition, and to 1 intervention - of which Shear-Wave Elastography is the first listed.
NCT03106337 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03106337 about?
NCT03106337 is a clinical study titled "Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid". As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery fo...
What is the current status of trial NCT03106337?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2010-01. Estimated completion is 2012-04.
What conditions does trial NCT03106337 study?
This clinical trial studies the following conditions: Thyroid Nodule, Follicular Neoplasm.
What interventions are being tested in trial NCT03106337?
The interventions under investigation include: Shear-Wave Elastography (DEVICE).
Who is sponsoring clinical trial NCT03106337?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03106337 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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