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DE-CT in Lung Cancer Proton Therapy (DE-CT)

13. april 2017 oppdatert av: Maastricht Radiation Oncology

DE-CT vs. SE-CT as Optimal Imaging During Treatment for Adaptive Proton Therapy in Stage III Non Small Cell Lung Cancer (NSCLC)

Dose distribution calculations for proton therapy are more accurate when based on DE-CT than on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations is for lung cancer patients.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In order to calculate the dose distribution of protons adequately, accurate estimations of the stopping power ratio (SPR) medium to water, are required. Using a conversion from single energy CT (SE-CT) images results in an uncertainty in the SPR of at least 3-4%. This uncertainty results in in the use of larger margins around the clinical target volume (CTV) and hence more dose to the organs at risk (OAR). It also effects in the conservative use of beam directions, which are often sub-optimal, to avoid irradiating normal tissues.

Dual energy CT (DE-CT) improves the accuracy of the SPR and therefore the proton range estimation.

An evaluation of the proton range for several tissues using SE-CT and DE-CT as input to Monte Carlo (MC) simulations showed on average improvements in range prediction from 0.1% to 2.1% when using DECT instead of SECT, but in several phantoms and also versus proton-CT, the errors on SE-CT based proton stopping power ratios are reported to be more than 7 %.

A limitation of these studies is that most of them were performed in phantoms. In the first clinical data set on five patients with base of skull tumours, it was reported that although the SPR estimation was indeed better for DE-CT than for SE-CT, its clinical relevance was unclear. However, in the same study, phantom measurements showed a large uncertainty of the SPR in the lung. This is due to the large heterogeneity of the lungs and the huge difference in the density of the lungs compared to the mediastinum, the tumour and the chest cavity.

It is therefore important to study the SPR differences of SE-CT compared to DE-CT in lung cancer patients and the impact on the dose distribution especially in the context of adaptive radiotherapy. As during the course of concurrent chemotherapy and radiotherapy, which is the standard treatment in the majority of stage III lung cancer patients, important anatomical changes may occur, it is also of clinical relevance to determine the influence of repeated dose calculations on DE-CT.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Nederland
    • Limburg
      • Maastricht, Limburg, Nederland, 6229 ET
        • Maastro Clinic

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
  • Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
  • Able to give written informed consent
  • Able to have adequate contraception in woman with child bearing potential

Exclusion Criteria:

  • Not able to give written informed consent
  • Not able to comply with adequate contraception in woman with child bearing potential

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Scans
Patients included in the trial will receive DE-CT in stead of SE-CT's.
Fremgangsmåte: DE-CT's and SE-CT
Patients included in the trial will receive 3 extra DE-CT's and 3 extra SE-CT's

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dose distribution on the CTV (measured in Gy)
Tidsramme: Measured during 2nd and 4th week of radiation treatment
Dose distribution on the CTV (clinical target volume) of the tumour and the lymph nodes of DE-CT vs. SE-CT
Measured during 2nd and 4th week of radiation treatment
Dose distribution on the OAR (measured in Gy)
Tidsramme: Measured during 2nd and 4th week of radiation treatment
Dose distribution on the OAR (organs at risk), lungs, heart, aorta, pulmonary artery, superior vena cava, oesophagus, spinal cord, vertebral body, of DE-CT vs. SE-CT
Measured during 2nd and 4th week of radiation treatment

Samarbeidspartnere og etterforskere

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

Sponsor

Maastricht Radiation Oncology

Etterforskere

  • Hovedetterforsker: Dirk De Ruysscher, MD, PhD, Maastro Clinic, The Netherlands

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. september 2016

Primær fullføring (Forventet)

1. september 2017

Studiet fullført (Forventet)

1. desember 2017

Datoer for studieregistrering

Først innsendt

19. juli 2016

Først innsendt som oppfylte QC-kriteriene

21. juli 2016

Først lagt ut (Anslag)

26. juli 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. april 2017

Sist bekreftet

1. august 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DE-CT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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. .

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