Cervical CancerGENIUSNCT02503917
Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound
An observational study of Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Julie Curtis, 02086713873, julie.curtis@rmh.nhs.uk
Sarah Mason
About this study
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.
Read the 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.
- Conditions
- Cervical Cancer
- Keywords
- Imaging, Ultrasound, Image-guided radiotherapy, Cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour
The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.
Measured: 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
A small COV will indicate greater clinician/expert confidence in segmenting the uterus
Measured: COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy
Secondary outcomes (5)
Bland-Altman plot (healthy volunteer cohort)
Used to describe the level of agreement between MR and ultrasound images of the uterus.
Measured: 1 day
Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
Assess both inter- and intra- fractional motion of the uterus.
Measured: 3 days
Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR
Measured: from data collected over 3 days
Bland-Altman plot (patient volunteer cohort)
describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.
Measured: 6 weeks
Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.
Measured: from data collected over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Susan Lalondrelle, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503917
- Sponsor's protocol ID
- CCR4342
- Acronym
- GENIUS
- Status last verified
- May 2016
- First submitted
- 17 Jul 2015
- Last updated
- 23 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound
- ClinicalTrials.gov ID
- NCT02503917
- Acronym / sponsor ID
- GENIUS / CCR4342
- Conditions
- Cervical Cancer
- Keywords
- Imaging, Ultrasound, Image-guided radiotherapy, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
5 secondary outcomes
Bland-Altman plot (healthy volunteer cohort)
Time frame: 1 day
Uterine center of mass displacement on ultrasound (healthy volunteer cohort)
Time frame: 3 days
Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)
Time frame: from data collected over 3 days
Bland-Altman plot (patient volunteer cohort)
Time frame: 6 weeks
Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)
Time frame: from data collected over 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Lalondrelle principal investigator
Royal Marsden Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Curtis (02086713873, julie.curtis@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.