- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05176860
Evaluering av Novel Cone-Beam CT for veiledning og tilpasning av presisjonsstrålebehandling
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Denne studien fokuserer på potensielle fordeler med et høyytelses kjeglestråle CT (CBCT) bildeveiledningssystem for forbedret presisjon ved levering av strålebehandling. CBCT brukes for tiden under strålebehandling for å tilpasse pasienten til sin opprinnelige behandlingsplan for å øke presisjonen av strålelevering. Den nåværende CBCT-bildeteknologien krever omtrent et minutt å få et bilde. For å skaffe bilder med tilstrekkelig kvalitet til å tillate nøyaktig målretting, kan det hende at pasienten må utføre flere pustemanøvrer for å "fryse" bevegelsen til svulster som beveger seg med pustesyklusen (f.eks. lunge-, lever- og brystsvulster). Den nye høyytelses CBCT kan ta et bilde på omtrent 6 sekunder, noe som muligens muliggjør innhenting av bilder med et enkelt pusthold. Forbedrede bevegelseskompensasjonsalgoritmer som brukes i bilderekonstruksjon kan tillate innhenting av bilder av god kvalitet selv mens en pasient ikke holder pusten.
Metodikken for pasientens behandlingsoppsett, CT-simulering, behandlingsplanlegging, bildeveiledning og behandlingslevering vil bli bestemt av pasientens behandlingsteam og er ikke spesifisert av denne studien. Registrering i studien kan skje etter at behandlingslevering har startet, men må være før den femte fraksjon.
Etter fullføring av informert samtykke til å delta i denne studien, vil høyytelses CBCT-avbildning planlegges umiddelbart før eller etter en av forsøkspersonens første fem planlagte strålebehandlingsfraksjoner. To forsknings-CBCT-bilder vil bli innhentet, ett med pustestopp, det andre med fri pust.
Med minimal forstyrrelse for deltakende pasienter, vil denne studien muliggjøre en sammenligning av (i) pasientens behandlingsplanlegging viftestråle-CT og (ii) den konvensjonelle CBCT anskaffet på en eksisterende behandlingsenhet med (iii) høyytelses CBCT. Bildekvaliteten til CBCT-bildedataene med høy ytelse vil dermed bli sammenlignet med både en best-case-standard (viftestråle) og status quo for bildebehandling på sofaen for å isolere og identifisere forbedringer.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2E2
- Nova Scotia Health (QEII)
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Emnet er planlagt for behandling på en av de fem TrueBeam-plattformene på NS Health QE2-nettstedet.
- Personen mottar strålebehandling ved hjelp av en pusteteknikk (for eksempel lunge-, lever- og venstre brystkreft).
Ekskluderingskriterier:
- Pasienten er gravid eller har planer om graviditet i løpet av behandlingsperioden.
- Pasienten er uvillig til å samtykke til å delta i studien, eller for hvem informert samtykke ikke er mulig.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Høyytelses CBCT-avbildning
To ekstra studiebildesett er anskaffet.
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To forsknings-CBCT-bilder vil bli anskaffet per emne.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CBCT Image Quality - Artifact Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dosimetry Calculations - Gamma Pass Rate
Tidsramme: 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
Tidsramme: 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
|
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Dosimetry Calculations - Target DVH Dose Metrics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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".
|
1 Day
|
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Patient Experience - Ease of Breath Hold on TrueBeam
Tidsramme: 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
Tidsramme: 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".
|
1 Day
|
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Patient Experience - Relative Ease of Breath Hold Between Machines
Tidsramme: 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
Tidsramme: 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".
|
1 Day
|
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Patient Experience - Overall Ethos Experience
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Lungesykdommer
- Leversykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Hudsykdommer
- Bryst sykdommer
- Hud- og bindevevssykdommer
- Lungeneoplasmer
- Brystneoplasmer
- Neoplasmer i leveren
Andre studie-ID-numre
- VAR-2021-12
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