- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02597452
Clinical Utility Study of a Low-Cost Hand-Held Breast Scanner (iBE)
연구 개요
상세 설명
The FDA approved class II device in this clinical trial is a low-cost hand-held breast scanner (intelligent Breast Exam, iBE). This device is to be used a pre-screening tool for mammograms or ultrasounds. Determination of the accuracy of iBE for the detection of clinically relevant breast lesions will be performed by means of a prospective study.
The iBE evaluation will be performed by a trained licensed practical nurse or ultrasound technologist who is blinded to the outcome of the radiology studies at the time the iBE is performed. The iBE training will be done by the leading iBE user in the United States. The iBE evaluation will be done prior to the patient's original scheduled imaging visit. After the completion of the imaging visit the radiologist will evaluate the mammogram and/or ultrasound images along with the iBE report.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Pennsylvania Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age and older
- Women and men with symptomatic breast lump (either by palpation or imaging) OR
- Asymptomatic women presenting to the imaging center for a screening mammogram
- Signed Informed Consent
Exclusion Criteria:
- Patients under 18 years of age
- Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: intelligent Breast Exam, iBE
Single Arm: Additional breast exam by a FDA approved hand-held intelligent breast exam device and a clinical breast exam during their scheduled breast screening appointment.
No return visit required for participation.
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A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual.
If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
이미징 결과를 사용하여 장치의 감도를 추정하여 iBE 검사의 결과를 임상 유방 검사(CBE)와 비교
기간: 영상 스캔 후 약 1개월
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iBE 및 CBE의 계산된 민감도 또는 실제 양성 유방 병변의 백분율(영상 결과 기반) 비교
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영상 스캔 후 약 1개월
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Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
기간: approximately one month after imaging
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comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE
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approximately one month after imaging
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Position of the Breast Lesion as Measured by iBE and Mammography
기간: approximately one month after imaging
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agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.
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approximately one month after imaging
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Size Detection of the Breast Lesions Identified by iBE
기간: approximately one month after imaging
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The size detected of the breast lesion (cm) by mammogram or ultrasound
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approximately one month after imaging
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Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected
기간: through study completion an average of 18 months
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comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
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through study completion an average of 18 months
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Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected
기간: through study completion an average of 18 months
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comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam
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through study completion an average of 18 months
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Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level
기간: through study completion an average of 18 months
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breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results
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through study completion an average of 18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ari D Brooks, MD, University of Pennsylvania
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 821412-UPCC24114
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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