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Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)

20. Mai 2016 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Gebärmutterhalskrebs

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigtes Königreich
- Surrey
  - Sutton, Surrey, Vereinigtes Königreich, SM2 5PT
    - Rekrutierung
    - Royal Marsden Hospital NHS Foundation Trust
    - Kontakt:
      
      Julie Curtis
      
      Telefonnummer: 02086713873
      
      E-Mail: julie.curtis@rmh.nhs.uk
    - Unterermittler:
      
      Sarah Mason

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Beobachtungsmodelle: Kohorte
Zeitperspektiven: Interessent

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Bland-Altman plot (healthy volunteer cohort) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Royal Marsden NHS Foundation Trust

Mitarbeiter

Institute of Cancer Research, United Kingdom

Ermittler

Hauptermittler: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2015

Primärer Abschluss (Voraussichtlich)

1. September 2016

Studienabschluss (Voraussichtlich)

1. Oktober 2016

Studienanmeldedaten

Zuerst eingereicht

17. Juli 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat