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Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02503917
Acronym
GENIUS
Enrollment
25
Registered
2015-07-21
Start date
2015-09-30
Completion date
2016-10-31
Last updated
2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Imaging, Ultrasound, Image-guided radiotherapy, Cancer

Brief summary

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.

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.

Interventions

None listed

Sponsors

Institute of Cancer Research, United Kingdom
CollaboratorOTHER
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contourDSC 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.
Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCTCOV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapyA small COV will indicate greater clinician/expert confidence in segmenting the uterus

Secondary

MeasureTime frameDescription
Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)from data collected over 3 daysDetermine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
Bland-Altman plot (healthy volunteer cohort)1 dayUsed to describe the level of agreement between MR and ultrasound images of the uterus.
Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)from data collected over 6 weeksDetermine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
Bland-Altman plot (patient volunteer cohort)6 weeksdescribe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
Uterine center of mass displacement on ultrasound (healthy volunteer cohort)3 daysAssess both inter- and intra- fractional motion of the uterus.

Countries

United Kingdom

Contacts

Primary ContactJulie Curtis
julie.curtis@rmh.nhs.uk02086713873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026