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Evaluatie van nieuwe Cone-Beam CT voor begeleiding en aanpassing van precisieradiotherapie
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Deze studie richt zich op de mogelijke voordelen van een hoogwaardig cone beam CT (CBCT) beeldgeleidingssysteem voor verbeterde precisie bij het toedienen van radiotherapie. CBCT wordt momenteel gebruikt tijdens bestralingstherapie om de patiënt af te stemmen op hun oorspronkelijke behandelplan om de precisie van de bestraling te vergroten. De huidige CBCT-beeldvormingstechnologie heeft ongeveer een minuut nodig om een beeld te verkrijgen. Om beelden te verkrijgen met voldoende kwaliteit om nauwkeurig richten mogelijk te maken, moet de patiënt mogelijk meerdere adem inhoudingsmanoeuvres uitvoeren om de beweging van tumoren die met de ademhalingscyclus meebewegen te "bevriezen" (bijv. long-, lever- en borsttumoren). De nieuwe hoogwaardige CBCT kan een beeld verwerven in ongeveer 6 seconden, waardoor mogelijk beelden kunnen worden verkregen met een enkele adempauze. Verbeterde algoritmen voor bewegingscompensatie die bij beeldreconstructie worden gebruikt, kunnen het mogelijk maken om beelden van goede kwaliteit te verkrijgen, zelfs als een patiënt zijn adem niet inhoudt.
De methodologie voor de behandelingsopzet, CT-simulatie, behandelingsplanning, beeldgeleiding en behandelingsafgifte van de proefpersoon zal worden bepaald door het behandelteam van de proefpersoon en wordt niet gespecificeerd door dit onderzoek. Inschrijving in het onderzoek kan plaatsvinden nadat de behandeling is gestart, maar moet vóór de vijfde fractie plaatsvinden.
Na voltooiing van de geïnformeerde toestemming om deel te nemen aan dit onderzoek, zal hoogwaardige CBCT-beeldvorming onmiddellijk vóór of na een van de eerste vijf geplande bestralingsbehandelingsfracties van de proefpersoon worden gepland. Er zullen twee onderzoeks-CBCT-beelden worden verkregen, één met adem inhouden, de andere met vrije ademhaling.
Met minimale verstoring voor deelnemende patiënten, zal deze studie een vergelijking mogelijk maken van (i) de behandelplanning van de proefpersoon met waaierstraal-CT en (ii) de conventionele CBCT verkregen op een bestaande behandeleenheid met (iii) de hoogwaardige CBCT. De beeldkwaliteit van de hoogwaardige CBCT-beeldgegevens zal daarbij worden vergeleken met zowel een best-case standaard (waaierstraal) als de status-quo voor beeldvorming op de bank om verbeteringen te isoleren en te identificeren.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2E2
- Nova Scotia Health (QEII)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- Onderwerp is gepland voor behandeling op een van de vijf TrueBeam-platforms op de NS Health QE2-site.
- Proefpersoon krijgt bestralingstherapie waarbij de adem wordt ingehouden (bijvoorbeeld long-, lever- en linkerborstkanker).
Uitsluitingscriteria:
- Patiënt is zwanger of heeft plannen om zwanger te worden tijdens de behandelingsperiode.
- Patiënt is niet bereid toestemming te geven voor deelname aan het onderzoek, of voor wie geïnformeerde toestemming niet mogelijk is.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Hoogwaardige CBCT-beeldvorming
Er worden twee aanvullende onderzoeksbeeldvormingssets aangeschaft.
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Per onderwerp worden twee onderzoeks-CBCT-beelden verkregen.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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CBCT Image Quality - Artifact Index
Tijdsspanne: 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
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CBCT Image Quality - Image Nonuniformity
Tijdsspanne: 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
|
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CBCT Image Quality - Contrast
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dosimetry Calculations - Gamma Pass Rate
Tijdsspanne: 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
Tijdsspanne: 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.
|
1 day
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Dosimetry Calculations - Target DVH Dose Metrics
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Dosimetry Calculations - Abdomen OAR DVH Metrics
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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".
|
1 Day
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Patient Experience - Ease of Breath Hold on Ethos
Tijdsspanne: 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".
|
1 Day
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Patient Experience - Relative Ease of Breath Hold Between Machines
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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".
|
1 Day
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Longziekten
- Lever Ziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Huidziektes
- Borst ziekten
- Huid- en bindweefselaandoeningen
- Longneoplasmata
- Borstneoplasmata
- Lever neoplasmata
Andere studie-ID-nummers
- VAR-2021-12
Plan Individuele Deelnemersgegevens (IPD)
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