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Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)

20. maj 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Livmoderhalskræft

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Det Forenede Kongerige
- Surrey
  - Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
    - Rekruttering
    - Royal Marsden Hospital NHS Foundation Trust
    - Kontakt:
      
      Julie Curtis
      
      Telefonnummer: 02086713873
      
      E-mail: julie.curtis@rmh.nhs.uk
    - Underforsker:
      
      Sarah Mason

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kohorte
Tidsperspektiver: Fremadrettet

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Bland-Altman plot (healthy volunteer cohort) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Royal Marsden NHS Foundation Trust

Samarbejdspartnere

Institute of Cancer Research, United Kingdom

Efterforskere

Ledende efterforsker: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Forventet)

1. september 2016

Studieafslutning (Forventet)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

17. juli 2015

Først indsendt, der opfyldte QC-kriterier