- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05176860
Uuden kartiosäde-CT:n arviointi tarkkuussädehoidon ohjaamiseksi ja mukauttamiseksi
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Tässä tutkimuksessa keskitytään tehokkaan kartiosäde-CT (CBCT) -kuvanohjausjärjestelmän mahdollisiin hyötyihin sädehoidon tarkkuuden parantamiseksi. CBCT:tä käytetään tällä hetkellä sädehoidon aikana kohdistamaan potilas alkuperäiseen hoitosuunnitelmaansa säteilyn antamisen tarkkuuden lisäämiseksi. Nykyinen CBCT-kuvaustekniikka vaatii noin minuutin kuvan hankkimiseen. Saadakseen riittävän laadukkaita kuvia tarkan kohdistuksen mahdollistamiseksi, potilaan on ehkä suoritettava useita hengityspidätysliikkeitä hengityssyklin mukana liikkuvien kasvainten liikkeen "jäädyttämiseksi" (esim. keuhko-, maksa- ja rintakasvaimet). Uusi korkean suorituskyvyn CBCT pystyy hankkimaan kuvan noin 6 sekunnissa, mikä mahdollistaa kuvien ottamisen yhdellä hengityksen pidätyksellä. Parannetut liikkeen kompensointialgoritmit, joita käytetään kuvan rekonstruktiossa, voivat mahdollistaa laadukkaiden kuvien saamisen, vaikka potilas ei pidättele hengitystään.
Potilaan hoitokokoonpanon, TT-simuloinnin, hoidon suunnittelun, kuvaohjauksen ja hoidon antamisen metodologian määrittää potilaan hoitotiimi, eikä sitä määritetä tässä tutkimuksessa. Tutkimukseen voi ilmoittautua hoidon aloittamisen jälkeen, mutta sen on oltava ennen viidettä fraktiota.
Kun tietoinen suostumus osallistua tähän tutkimukseen on saatu, korkean suorituskyvyn CBCT-kuvaus ajoitetaan välittömästi ennen yhtä koehenkilön viidestä ensimmäisestä suunnitellusta sädehoitofraktiosta tai sen jälkeen. Otetaan kaksi tutkimusta CBCT-kuvaa, joista toinen hengittää ja toinen vapaasti hengittää.
Tutkimukseen osallistuvien potilaiden häiriöt ovat minimaaliset, joten tämä tutkimus mahdollistaa (i) potilaan hoidon suunnittelun viuhka-CT:n ja (ii) olemassa olevan hoitoyksikön tavanomaisen CBCT:n vertailun (iii) tehokkaan CBCT:n kanssa. Korkean suorituskyvyn CBCT-kuvadatan kuvanlaatua verrataan siten sekä parhaan tapauksen standardiin (tuulettimen säde) että sohvalla tapahtuvan kuvantamisen status quoon parannusten eristämiseksi ja tunnistamiseksi.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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-
Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2E2
- Nova Scotia Health (QEII)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
- Kohdetta on määrä hoitaa yhdellä viidestä TrueBeam-alustasta NS Health QE2 -sivustolla.
- Kohde saa sädehoitoa hengityspidätystekniikalla (esimerkiksi keuhko-, maksa- ja vasemman rintasyövän syöpä).
Poissulkemiskriteerit:
- Potilas on raskaana tai suunnittelee raskautta hoidon aikana.
- Potilas ei ole halukas suostumaan tutkimukseen osallistumiseen tai jolle tietoinen suostumus ei ole mahdollista.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Tehokas CBCT-kuvaus
Lisäksi hankitaan kaksi tutkimuskuvaussarjaa.
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Kutakin kohdetta kohden otetaan kaksi tutkimusta CBCT-kuvaa.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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CBCT Image Quality - Artifact Index
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Dosimetry Calculations - Gamma Pass Rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
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1 day
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Dosimetry Calculations - Breast OAR DVH Metrics
Aikaikkuna: 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.
|
1 day
|
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Dosimetry Calculations - Lung OAR DVH Metrics
Aikaikkuna: 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
Aikaikkuna: 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.
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1 day
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Patient Experience - General Ease of Breath Hold
Aikaikkuna: 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
Aikaikkuna: 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".
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1 Day
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Patient Experience - Ease of Breath Hold on Ethos
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Hengityselinten sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Keuhkosairaudet
- Maksasairaudet
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Ihosairaudet
- Rintojen sairaudet
- Iho- ja sidekudostaudit
- Keuhkojen kasvaimet
- Rintojen kasvaimet
- Maksan kasvaimet
Muut tutkimustunnusnumerot
- VAR-2021-12
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