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

A Pilot Study Using Magnetic Resonance (MR) to Assess Cervix Motion During Radiotherapy Treatment. (MR Cervix)

1. august 2019 oppdatert av: Sally Falk, The Christie NHS Foundation Trust

The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around half of patients with up to 10% suffering from grade 3-4 toxicity.

The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the risk of long and short term toxicity (although there is little randomized evidence). However pelvic organ position varies both between and even during radiotherapy fractions; this means that radiotherapy margins must be generous to allow adequate coverage of the clinical target volume (CTV) but this also increases dose to OARs.

There have been a number of studies evaluating pelvic organ motion in cervical cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using cone beam computed tomography (CBCT) imaging which is often poor quality with limited soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for imaged guided brachytherapy treatment.

This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer with development of a number of theoretical treatment strategies.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients will undergo standard treatment during the study with five weeks of external beam radiotherapy (25 fractions) followed by a MR guided brachytherapy boost or external beam boost (further 10 fractions.) They will be treated with weekly cisplatin 40mg/m2 if clinically appropriate.

As part of standard treatment patients have a staging MR scan at diagnosis, a radiotherapy planning CT and an MR scan in the 4th week of treatment. Cone beam imaging will also be performed. Response will be assessed as standard with a MR scan at 3 months.

As part of the study patients will undergo 3 additional MR scans. These will take place in the 1st, 2nd and 5th weeks of treatment. Extra sequences will be added to the clinical mid-point scan in the 4th week of treatment. These MR scans will include anatomical images - with full and empty bladder as well as cine data (with a scan every minute for 10 minutes) to assess intra fraction motion. They will also include a DWI sequence, which will be used to assess if early prediction of response is possible. The frequency of cone beam imaging will be increased from approximately 10 scans as standard of care to 25 scans to allow for daily imaging.

The 1st MR scan will be contoured to outline clinical target volumes (CTVs) and OARs. A variety of planning strategies will be developed including standard planning target volume (PTV) margins, a plan of the day (POTD) approach, a POTD+ as well as an online adaptation model. These models will be used to assess coverage of CTV and PTV as well as dose to OARs using the scans obtained during the radiotherapy treatment. The practicality of each approach will also be assessed. Inter and intra fraction organ motion will also be analysed in order to develop patient specific models.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Storbritannia
    • Greater Manchester
      • Manchester, Greater Manchester, Storbritannia, M20 4BX
        • The Christie NHS Foundation Trust

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

Hunn

Beskrivelse

Inclusion Criteria:

  • Histologically confirmed diagnosis of cervical cancer
  • Treatment with primary curative intent
  • Undergoing external beam radiotherapy (+/-chemotherapy) followed by brachytherapy or an external beam boost
  • Age over 18

Exclusion Criteria:

  • Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form (see appendix 1)
  • Previous hysterectomy
  • Unable to tolerate MR scans
  • Metastatic disease
  • Pregnancy

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
Eksperimentell: MR scans
As part of the study patients will undergo 3 additional MR scans during radiotherapy treatment. These will take place in the 1st, 2nd and 5th weeks of treatment.
Annen: MR scans
Additional imaging using MR scans.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
Tidsramme: 18 months
Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
Tidsramme: 18 months
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
18 months
Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
Tidsramme: 18 months
Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
18 months

Samarbeidspartnere og etterforskere

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

Sponsor

The Christie NHS Foundation Trust

Etterforskere

  • Hovedetterforsker: Marcel van Herk, University of Manchester
  • Hovedetterforsker: Ananya Choudhury, The Christie NHS Foundation Trust

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 (Faktiske)

1. september 2017

Primær fullføring (Faktiske)

1. desember 2018

Studiet fullført (Faktiske)

1. mars 2019

Datoer for studieregistrering

Først innsendt

16. mars 2017

Først innsendt som oppfylte QC-kriteriene

29. mars 2017

Først lagt ut (Faktiske)

5. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 17_RADIO_122

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

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. .

Kliniske studier på Livmorhalskreft

Kliniske studier på MR scans

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Liberia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere