Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Influence of Couch Tracking Motion

2. mai 2018 oppdatert av: University of Zurich

Influence of Couch Tracking Motion on Physiological Parameters

Tumor motion increases the uncertainty in Radiation Oncology. Couch tracking can compensate for this uncertainty. However it is not known if the couch motion influences the respiratory pattern of the patients. This will be evaluated in this study on healthy volunteers.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Radiation therapy is one of the main options in cancer treatments, alongside surgery and chemotherapy. Its efficacy largely depends on the absorbed radiation dose of the tumor cells. However, the irradiation of healthy cells results in negative side effects for the patient. Therefore, a big challenge in radiation therapy is to irradiate the tumor with sufficient dose, while keeping the irradiation of the healthy tissue reasonably low. Currently, the radiation treatment is planned by defining a volume enclosing the tumor, but with added margins to account for any uncertainties. These margins ensure that the tumor receives the prescribed dose.

Tumor motion contributes to the uncertainties. The tumor motions of tumors in different sites have different causes, but for this project the focus is on thoracic, liver, and adrenal gland tumors. The motion of these tumor types is mainly caused by the patient's respiration. So, the tumor motion pattern depends on the respiration pattern of the patient. The motion of lung tumors has been reported to have a peak-to-peak amplitude of up to 24 mm. Currently, the tumor motion is handled by enlarging the margins, such that the tumor is always inside the defined volume. But enlarging the margins also results in an increase of irradiated volume consisting of healthy tissue.

Tumor motion mitigation is concerned with reducing the margin increase caused by the motion of the tumor. There are several approaches to tumor motion mitigation and the one under consideration in this project is the tumor tracking approach, the technically most difficult approach. In tumor tracking the tumor motion is continuously compensated by moving the radiation source modifying the radiation beam, or moving the patient, which is denoted as couch tracking.

In couch tracking, the patient is moved by the robotic treatment couch. Such robotic treatment couches are in use with conventional, widely available C-arm linear accelerators, and, therefore, are readily available for implementing couch tracking. The patient is placed on a couch which moves in the opposite direction of the tumor motion. The goal is to minimize the patient's tumor motion relative to the radiation, which in turn allows the margins to be decreased. The margin decrease might ultimately lead to a reduction of side effects, e.g. pneumonitis.

The motion of the couch depends on the motion of the tumor, which in turn depends on the respiration of the patient. However, the couch motion may influence the patient's well being or the patient's respiration. So the question arises: Does the motion of the couch have an influence on the respiration behavior? And also: Does the motion of the couch have an influence on the well being (motion sickness)? And are the well-being and the respiration behavior connected? If the respiration behavior does depend on the couch motion, it may be necessary to control the respiration behavior. Additionally, in the study, the investigators will check an assumption in couch tracking, namely that the patient's body is rigidly fixed to the couch. If this assumption does not hold, the motion of the patient's body relative to the couch will have to be taken into account in couch tracking.

Studietype

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Zurich, Sveits, 8091
        • University Hospital Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy volunteers
  • Male and Female subjects
  • ≥18 and ≤100 years
  • Written informed consent by the participant after information about the project
  • German speaking

Exclusion Criteria:

  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Body weight exceeding 200kg

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Tracking
The volunteers will be placed on the treatment couch. Their respiratory motion will be measured and the treatment couch will be moved accordingly. During the couch motion experiment the heartbeat, the skin humidity, the respiratory characteristics and the pupil motion will be additionally measured.
The treatment couch will be moved according to the respiratory motion of the patient. As a reference first the respiration will be measured without couch motion, than the couch will be switched on and we will evaluate if the respiration changes due to the motion of the couch. This procedure will be repeated once.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Respiratory amplitude
Tidsramme: baseline and 20 min
Change of respiratory motion due to couch motion. Respiration will be measured on the chest wall using a contact-free measurement.
baseline and 20 min

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart beat
Tidsramme: baseline and 20 min
The heart beat will be measured on the palm of the hand during the static and the couch motion phase.
baseline and 20 min
Skin humidity
Tidsramme: baseline and 20 min
The skin humidity will be measured on the hand palm during the static and the phase in motion.
baseline and 20 min
Pupil motion
Tidsramme: baseline and 20 min
The change in pupil motion during tracking compared to static condition will be assessed using eye tracking glasses.
baseline and 20 min
Body motion
Tidsramme: baseline and 20 min
The influence of the couch motion on the body motion will be assessed using a surface detection system.
baseline and 20 min
Motion sickness
Tidsramme: baseline and 20 min
With a questionaire the motion sickness is assessed, which the participants might experience during couch motion
baseline and 20 min

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Matthias Guckenberger, MD, University Hospital Zurich, Department of Radiation Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2016

Primær fullføring (Faktiske)

1. april 2018

Studiet fullført (Faktiske)

1. april 2018

Datoer for studieregistrering

Først innsendt

20. juni 2016

Først innsendt som oppfylte QC-kriteriene

28. juni 2016

Først lagt ut (Anslag)

1. juli 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2016-00163

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Respirasjonsamplitude

Kliniske studier på Protura Treatment table

3
Abonnere