- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05176860
Ocena nowatorskiej tomografii komputerowej z wiązką stożkową do prowadzenia i adaptacji precyzyjnej radioterapii
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Niniejsze badanie koncentruje się na potencjalnych korzyściach płynących z wysokowydajnego systemu prowadzenia obrazu CT (CBCT) w celu zwiększenia precyzji w dostarczaniu radioterapii. CBCT jest obecnie stosowana podczas radioterapii w celu dostosowania pacjenta do pierwotnego planu leczenia w celu zwiększenia precyzji dostarczania promieniowania. Obecna technologia obrazowania CBCT wymaga około minuty na uzyskanie obrazu. Aby uzyskać obrazy o jakości wystarczającej do dokładnego celowania, pacjent może być zmuszony do wykonania wielu manewrów wstrzymania oddechu w celu „zamrożenia” ruchu guzów poruszających się wraz z cyklem oddychania (np. nowotwory płuc, wątroby i piersi). Nowy wysokowydajny tomograf CBCT może uzyskać obraz w ciągu około 6 sekund, co potencjalnie umożliwia pozyskiwanie obrazów przy jednym wstrzymaniu oddechu. Udoskonalone algorytmy kompensacji ruchu stosowane w rekonstrukcji obrazu mogą pozwolić na uzyskanie dobrej jakości obrazu nawet wtedy, gdy pacjent nie wstrzymuje oddechu.
Metodologia konfiguracji leczenia pacjenta, symulacji CT, planowania leczenia, wskazówek obrazowych i prowadzenia leczenia zostanie określona przez zespół terapeutyczny pacjenta i nie jest określona w tym badaniu. Włączenie do badania może nastąpić po rozpoczęciu leczenia, ale musi nastąpić przed podaniem piątej frakcji.
Po wyrażeniu świadomej zgody na udział w tym badaniu, wysokowydajne obrazowanie CBCT zostanie zaplanowane bezpośrednio przed lub po jednej z pierwszych pięciu zaplanowanych frakcji radioterapii pacjenta. Zostaną uzyskane dwa badawcze obrazy CBCT, jeden ze wstrzymanym oddechem, a drugi ze swobodnym oddychaniem.
Przy minimalnym zakłóceniu dla uczestniczących pacjentów badanie to umożliwi porównanie (i) tomografii komputerowej z wiązką wachlarzową pacjenta do planowania leczenia oraz (ii) konwencjonalnej CBCT uzyskanej na istniejącym oddziale terapeutycznym z (iii) wysokowydajną CBCT. Jakość obrazu wysokowydajnych danych obrazu CBCT zostanie w ten sposób porównana zarówno z najlepszym standardem (wiązka wachlarzowa), jak i ze statusem quo dla obrazowania na kanapie w celu wyizolowania i zidentyfikowania ulepszeń.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 2E2
- Nova Scotia Health (QEII)
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Opis
Kryteria przyjęcia:
- Pacjent ma zaplanowane leczenie na jednej z pięciu platform TrueBeam w ośrodku NS Health QE2.
- Podmiot otrzymuje radioterapię przy użyciu techniki wstrzymywania oddechu (na przykład rak płuc, wątroby i lewej piersi).
Kryteria wyłączenia:
- Pacjentka jest w ciąży lub planuje ciążę w okresie leczenia.
- Pacjent nie chce wyrazić zgody na udział w badaniu lub dla którego świadoma zgoda nie jest możliwa.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Wysokowydajne obrazowanie CBCT
Nabywane są dwa dodatkowe zestawy obrazowania do badań.
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Dla każdego pacjenta zostaną uzyskane dwa badawcze obrazy CBCT.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
CBCT Image Quality - Artifact Index
Ramy czasowe: 1 day
|
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
|
|
CBCT Image Quality - Image Nonuniformity
Ramy czasowe: 1 day
|
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
|
|
CBCT Image Quality - Contrast
Ramy czasowe: 1 week
|
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
Ramy czasowe: 1 week
|
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
|
|
CBCT Image Quality - HU Similarity to CT Simulation
Ramy czasowe: 1 week
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Dosimetry Calculations - Gamma Pass Rate
Ramy czasowe: 1 day
|
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.
|
1 day
|
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Dosimetry Calculations - Target DVH Volume Metrics
Ramy czasowe: 1 day
|
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.
|
1 day
|
|
Dosimetry Calculations - Target DVH Dose Metrics
Ramy czasowe: 1 day
|
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.
|
1 day
|
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Dosimetry Calculations - Breast OAR DVH Metrics
Ramy czasowe: 1 day
|
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.
|
1 day
|
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Dosimetry Calculations - Lung OAR DVH Metrics
Ramy czasowe: 1 day
|
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.
|
1 day
|
|
Dosimetry Calculations - Abdomen OAR DVH Metrics
Ramy czasowe: 1 day
|
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.
|
1 day
|
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Patient Experience - General Ease of Breath Hold
Ramy czasowe: 1 Day
|
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
Ramy czasowe: 1 Day
|
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".
|
1 Day
|
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Patient Experience - Ease of Breath Hold on Ethos
Ramy czasowe: 1 Day
|
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
|
|
Patient Experience - Relative Ease of Breath Hold Between Machines
Ramy czasowe: 1 Day
|
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".
|
1 Day
|
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Patient Experience - Overall TrueBeam Experience
Ramy czasowe: 1 Day
|
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".
|
1 Day
|
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Patient Experience - Overall Ethos Experience
Ramy czasowe: 1 Day
|
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".
|
1 Day
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby Układu Oddechowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby płuc
- Choroby wątroby
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Choroby skórne
- Choroby piersi
- Choroby skóry i tkanki łącznej
- Nowotwory płuc
- Nowotwory piersi
- Nowotwory wątroby
Inne numery identyfikacyjne badania
- VAR-2021-12
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .