Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound (GENIUS)

May 20, 2016 updated by: 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.

Study Overview

Status

Unknown

Conditions

Cervical Cancer

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- Surrey
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden Hospital NHS Foundation Trust
    - Contact:
      
      Julie Curtis
      
      Phone Number: 02086713873
      
      Email: julie.curtis@rmh.nhs.uk
    - Sub-Investigator:
      
      Sarah Mason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour Time Frame: 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 Time Frame: 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bland-Altman plot (healthy volunteer cohort) Time Frame: 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) Time Frame: 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) Time Frame: 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) Time Frame: 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) Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Institute of Cancer Research, United Kingdom

Investigators

Principal Investigator: Susan Lalondrelle, Royal Marsden Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria