Clinical trial NCT02503917: Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: Imaging, Ultrasound
Image-guided radiotherapy
Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2015-07-21
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
timeFrame: DSC calculated at 24 time points for each healthy volunteer (3 days)
measure: Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT
timeFrame: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
Secondary outcomes:
measure: Bland-Altman plot (healthy volunteer cohort)
timeFrame: 1 day
measure: Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
timeFrame: 3 days
measure: Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
timeFrame: from data collected over 3 days
measure: Bland-Altman plot (patient volunteer cohort)
timeFrame: 6 weeks
measure: Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
timeFrame: from data collected over 6 weeks
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden Hospital NHS Foundation Trust
name: Susan Lalondrelle
role: PRINCIPAL_INVESTIGATOR
References: