Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound

NCT02503917 | Unknown

• 1 other identifier: CCR4342
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Imaging, Ultrasound; Image-guided radiotherapy; Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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)

  1 day

• Uterine center of mass displacement on ultrasound (healthy volunteer cohort)

  3 days

• Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)

  from data collected over 3 days

• Bland-Altman plot (patient volunteer cohort)

  6 weeks

• Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)

  from data collected over 6 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Susan Lalondrelle

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Curtis

CONTACT

02086713873; julie.curtis@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 21, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

GB (1)