- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03307694
Thyroid Ultrasound Elasticity (TrUE) Imaging
Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory Univeristy Hospital Midtown
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥ 18 years old
- Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
MAC-SWEI, standard SWEI, ultrasound
Participants in this group will receive all three imaging techniques
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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.
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.
다른 이름들:
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.
다른 이름들:
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Standard SWEI, ultrasound
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.
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Determination of Malignancy by SWEI Imaging
기간: Pre-operative visit (within 24 hours before surgery, on average)
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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.
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Pre-operative visit (within 24 hours before surgery, on average)
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Determination of Malignancy by Pathological Proof
기간: Post-surgery (within 10 days after surgery, on average)
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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.
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Post-surgery (within 10 days after surgery, on average)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Accuracy of differentiating benign from malignant lesions between SWEI techniques
기간: Pre-operative visit (within 24 hours before surgery, on average)
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The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.
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Pre-operative visit (within 24 hours before surgery, on average)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Stanislav Emelianov, PhD, Emory University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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