- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02503917
Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)
연구 개요
상태
정황
상세 설명
Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.
Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
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Surrey
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Sutton, Surrey, 영국, SM2 5PT
- 모병
- Royal Marsden Hospital NHS Foundation Trust
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연락하다:
- Julie Curtis
- 전화번호: 02086713873
- 이메일: julie.curtis@rmh.nhs.uk
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부수사관:
- Sarah Mason
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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:
- healthy volunteer cohort: Healthy female adult volunteers
- patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
Exclusion Criteria:
- both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
|---|
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Healthy volunteers
Healthy female adult volunteers
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Cervical cancer patients
Patients receiving radiotherapy for cervical cancer at the Royal Marsden who will receive a planning CT scan and daily CBCT scanning as part of their treatment.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
기간: DSC calculated at 24 time points for each healthy volunteer (3 days)
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The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.
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DSC calculated at 24 time points for each healthy volunteer (3 days)
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Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT
기간: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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A small COV will indicate greater clinician/expert confidence in segmenting the uterus
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COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bland-Altman plot (healthy volunteer cohort)
기간: 1 day
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Used to describe the level of agreement between MR and ultrasound images of the uterus.
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1 day
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Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
기간: 3 days
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Assess both inter- and intra- fractional motion of the uterus.
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3 days
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Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
기간: from data collected over 3 days
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Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
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from data collected over 3 days
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Bland-Altman plot (patient volunteer cohort)
기간: 6 weeks
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describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
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6 weeks
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Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
기간: from data collected over 6 weeks
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Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
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from data collected over 6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CCR4342
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