- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05176860
정밀 방사선 치료의 지침 및 적응을 위한 새로운 Cone-Beam CT 평가
연구 개요
상세 설명
이 연구는 방사선 치료 전달의 정확도 향상을 위한 고성능 콘빔 CT(CBCT) 영상 유도 시스템의 잠재적 이점에 초점을 맞춥니다. CBCT는 현재 방사선 치료 중에 환자를 원래 치료 계획에 맞춰 방사선 전달의 정확도를 높이기 위해 사용됩니다. 현재 CBCT 이미징 기술은 이미지를 획득하는 데 약 1분이 소요됩니다. 정확한 타겟팅을 허용하기에 충분한 품질의 이미지를 획득하기 위해 환자는 호흡 주기와 함께 움직이는 종양의 움직임을 "동결"시키기 위해 여러 번의 숨 참기 조작을 수행해야 할 수 있습니다(예: 폐, 간, 유방 종양). 새로운 고성능 CBCT는 약 6초 만에 이미지를 획득할 수 있어 한 번의 숨 참기로 이미지를 획득할 수 있습니다. 이미지 재구성에 사용되는 개선된 동작 보상 알고리즘을 사용하면 환자가 숨을 참지 않는 동안에도 양질의 이미지를 얻을 수 있습니다.
피험자의 치료 설정, CT 시뮬레이션, 치료 계획, 이미지 안내 및 치료 전달을 위한 방법론은 피험자의 치료 팀에 의해 결정되며 이 연구에서 지정되지 않습니다. 치료 전달이 시작된 후에 연구에 등록할 수 있지만 5분의 1 이전이어야 합니다.
이 연구 참여에 대한 정보에 입각한 동의를 완료한 후 고성능 CBCT 이미징은 피험자의 처음 5개의 예정된 방사선 치료 부분 중 하나 직전 또는 직후에 예정됩니다. 두 개의 연구 CBCT 이미지를 획득합니다. 하나는 호흡 정지 상태이고 다른 하나는 자유 호흡 상태입니다.
참여 환자의 중단을 최소화하면서 이 연구를 통해 (i) 피험자의 치료 계획 팬빔 CT와 (ii) 기존 치료 장치에서 획득한 기존 CBCT를 (iii) 고성능 CBCT와 비교할 수 있습니다. 따라서 고성능 CBCT 이미지 데이터의 이미지 품질을 최선의 표준(팬 빔) 및 소파 위 이미징의 현상 유지와 비교하여 개선 사항을 분리하고 식별합니다.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2E2
- Nova Scotia Health (QEII)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 대상은 NS Health QE2 사이트에서 5개의 TrueBeam 플랫폼 중 하나에서 치료를 받을 예정입니다.
- 피험자는 숨참기 기술(예: 폐암, 간암 및 왼쪽 유방암)을 사용하여 방사선 요법을 받고 있습니다.
제외 기준:
- 환자는 임신 중이거나 치료 기간 동안 임신 계획이 있습니다.
- 환자가 연구 참여에 동의하지 않거나 정보에 입각한 동의가 불가능한 경우.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 고성능 CBCT 이미징
2개의 추가 연구 이미징 세트가 획득됩니다.
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피험자당 2개의 연구 CBCT 이미지를 획득합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CBCT Image Quality - Artifact Index
기간: 1 day
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Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion. AI = sqrt((STD_VOI)^2 - (STD_background)^2), where STD_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact. A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities. |
1 day
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CBCT Image Quality - Image Nonuniformity
기간: 1 day
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Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue. NU = (HU_max - HU_min)/(HU_max + HU_min), where HU_max and HU_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments). A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities. |
1 day
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CBCT Image Quality - Contrast
기간: 1 week
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Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs). Contrast = |HU1 - HU2| where HU1 and HU2 are the mean HU values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments). Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities. |
1 week
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CBCT Image Quality - Contrast to Noise Ratio
기간: 1 week
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Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background. CNR = |HU1 - HU2|/[0.5 (STD1 + STD2)] where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs. A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities. |
1 week
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CBCT Image Quality - HU Similarity to CT Simulation
기간: 1 week
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The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images. ΔHU = HU_CBCT - HU_CTSim, where HU_CBCT and HU_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively. The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities. |
1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dosimetry Calculations - Gamma Pass Rate
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm.
The gamma pass rate is expressed as a percentage of data points that meet the pass criteria.
A gamma pass rate of > 95% is typically considered acceptable for 3%/3mm.
As the gamma pass criteria become stricter, the pass rates decrease.
Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation.
Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation.
The median gamma pass rates across the entire study population are presented.
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1 day
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Dosimetry Calculations - Target DVH Volume Metrics
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions.
Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH.
The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median target DVH metric differences across the study population are presented.
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1 day
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Dosimetry Calculations - Target DVH Dose Metrics
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions.
Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH.
The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median target DVH metric differences across the study population are presented.
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1 day
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Dosimetry Calculations - Breast OAR DVH Metrics
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.
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1 day
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Dosimetry Calculations - Lung OAR DVH Metrics
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.
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1 day
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Dosimetry Calculations - Abdomen OAR DVH Metrics
기간: 1 day
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Every trial participant had a radiation treatment plan calculated on their CT simulation image series.
That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT.
Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions.
The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys.
The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported.
The smaller the difference, the greater the accuracy of the CBCT-based dose calculation.
Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.
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1 day
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Patient Experience - General Ease of Breath Hold
기간: 1 Day
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Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Ease of Breath Hold on TrueBeam
기간: 1 Day
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Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Ease of Breath Hold on Ethos
기간: 1 Day
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Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Relative Ease of Breath Hold Between Machines
기간: 1 Day
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Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".
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1 Day
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Patient Experience - Overall TrueBeam Experience
기간: 1 Day
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Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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Patient Experience - Overall Ethos Experience
기간: 1 Day
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Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
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1 Day
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공동 작업자 및 조사자
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. .