- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02123888
Simultaneous CBCT Acquisition During Arc Radiotherapy (SCART)
Simultaneous Cone Beam Computed Tomography (CBCT) Acquisition During Arc Radiotherapy
The cone beam image is a part of the radiotherapy treatment machine and uses lower energy xrays as the head of the radiotherapy machine moves around the patient in a circle. This takes pictures that give 3-dimensional information, somewhat like a CT scan. These images are better at showing the position of the tumour and surrounding soft tissues than the standard xrays that were previously used. Cone Beam Imaging Technology is not new and has been used regularly at The Christie for many years. The standard cone beam scan is taken before the actual radiotherapy treatment or after the treatment has been delivered.
Volumetric Modulated Arc Therapy (VMAT or Arc Radiotherapy) is a novel method of delivering radiotherapy that involves the continuous movement of the radiotherapy treatment machine head around the patient and MLC during radiation. Arc radiotherapy has been clinically implemented at The Christie for prostate radiotherapy treatments and work is in progress for implementation in lung radiotherapy. The continuous gantry rotation inherent to VMAT delivery makes this simultaneous imaging possible, although there are concerns associated with the impact that this may have on patient dose and image quality.
The aim of this research is to assess whether the image quality of cone beam scans taken during treatment are as good as standard cone beam scans taken before or after treatment used to determine the accuracy of patient position and the tumour coverage by radiotherapy.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Greater Manchester
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Manchester, Greater Manchester, 영국, M20 4BX
- 모병
- The Christie NHS Foundation Trust
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수석 연구원:
- Corinne Faivre-Finn
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부수사관:
- Ananya Choudhury
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연락하다:
- Julie Stratford
- 전화번호: 0044 (0)161 446 3506
- 이메일: julie.stratford@christie.nhs.uk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for prostate cancer patients:
- Patients to be treated with radical RT for prostate cancer
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
Inclusion Criteria for lung cancer patients:
- A histological or cytological diagnosis of non-small cell lung cancer or small cell lung cancer
- Patients to be treated with radical RT or SBRT
- Patients to be treated with VMAT
- ECOG performance status 0-2
- Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent
- Female patients must meet one of the following criteria - postmenopausal for a minimum of one year, surgically sterile, not pregnant, confirmed by β-HCG blood test and willing to use adequate contraception during study participation, not breastfeeding
Exclusion Criteria for prostate cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the pelvis that can make identification of normal anatomy difficult
Exclusion criteria for lung cancer patients:
- Clinical judgement by the investigator that the patient should not participate in the study
- Patients in clinical trials of new investigational medicinal products or treatment regimens unless there is written, prior agreement that the patient can also consent to this study, and that clinical data can also be used for this study
- Prior radiotherapy or surgery in the region of interest that can make identification of normal anatomy difficult
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cone Beam Computed Tomography
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy.
|
Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Equivalence of image quality
기간: 12 months
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To show equivalence of image quality from simultaneous CBCT acquisition during delivery of arc radiotherapy with that obtained from conventional CBCT acquisition in lung and prostate patients, as assessed by user-questionnaires.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quantify inter-observer variation
기간: 12 months
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To quantify inter-observer variation in interpretation of anatomy, as assessed by questionaires.
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12 months
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Quantify inter-observer variation
기간: 12 months
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To quantify inter-observer variation in delineation of specific structures on CBCT scans.
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12 months
|
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Quantify impact on treatment times.
기간: 12 months
|
To quantify the impact of simultaneous CBCT scans on treatment times.
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12 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ananya Choudhury, The Christie 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 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. .