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Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)

20 maj 2016 uppdaterad av: Royal Marsden NHS Foundation Trust
This study will establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.

Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Studietyp

Observationell

Inskrivning (Förväntat)

25

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Surrey
      • Sutton, Surrey, Storbritannien, SM2 5PT
        • Rekrytering
        • Royal Marsden Hospital NHS Foundation Trust
        • Kontakt:
        • Underutredare:
          • Sarah Mason

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

healthy volunteer cohort: Healthy female adult volunteers patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

Beskrivning

Inclusion Criteria:

  • healthy volunteer cohort: Healthy female adult volunteers
  • patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

Exclusion Criteria:

  • both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Healthy volunteers
Healthy female adult volunteers
Cervical cancer patients
Patients receiving radiotherapy for cervical cancer at the Royal Marsden who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
Tidsram: DSC calculated at 24 time points for each healthy volunteer (3 days)
The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.
DSC calculated at 24 time points for each healthy volunteer (3 days)
Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT
Tidsram: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
A small COV will indicate greater clinician/expert confidence in segmenting the uterus
COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bland-Altman plot (healthy volunteer cohort)
Tidsram: 1 day
Used to describe the level of agreement between MR and ultrasound images of the uterus.
1 day
Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
Tidsram: 3 days
Assess both inter- and intra- fractional motion of the uterus.
3 days
Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
Tidsram: from data collected over 3 days
Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
from data collected over 3 days
Bland-Altman plot (patient volunteer cohort)
Tidsram: 6 weeks
describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
6 weeks
Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
Tidsram: from data collected over 6 weeks
Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
from data collected over 6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2015

Primärt slutförande (Förväntat)

1 september 2016

Avslutad studie (Förväntat)

1 oktober 2016

Studieregistreringsdatum

Först inskickad

17 juli 2015

Först inskickad som uppfyllde QC-kriterierna

17 juli 2015

Första postat (Uppskatta)

21 juli 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

23 maj 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 maj 2016

Senast verifierad

1 maj 2016

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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