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Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;
  • Women aged over 18 years old;
  • Women willing to participant in this study evidenced by signing the informed consent.

Exclusion Criteria:

  • Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;
  • Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;
  • Women with mental abnormal;
  • Women did not cooperate or participate in other clinical trials;
  • Pregnant or lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Transvaginal Ultrasound diagnosis

    AI enabled Transvaginal Ultrasound diagnosis

    Arm Description

    radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm

    radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm

    Outcomes

    Primary Outcome Measures

    diagnostic accuracy
    diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer

    Secondary Outcome Measures

    time cost for Transvaginal Ultrasound image interpretation
    time cost for radiologists to interpret Transvaginal Ultrasound images

    Full Information

    First Posted
    December 28, 2019
    Last Updated
    October 6, 2021
    Sponsor
    Tongji Hospital
    Collaborators
    Hubei Cancer Hospital, Qilu Hospital of Shandong University, Henan Cancer Hospital, Xiangyang Central Hospital, The First People's Hospital of Jingzhou, First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04214782
    Brief Title
    Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
    Official Title
    Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tongji Hospital
    Collaborators
    Hubei Cancer Hospital, Qilu Hospital of Shandong University, Henan Cancer Hospital, Xiangyang Central Hospital, The First People's Hospital of Jingzhou, First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of >0.6. The modest diagnostic accuracy of TVU has risen some concerns about the over-treatment.Now, with the development of artificial intelligence (AI), we may have a better chance to interpret TVU imagines with high efficiency, reproducibility and accuracy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transvaginal Ultrasound diagnosis
    Arm Type
    No Intervention
    Arm Description
    radiologists interpretTransvaginal Ultrasound images without the help of Artificial Intelligence (AI) algorithm
    Arm Title
    AI enabled Transvaginal Ultrasound diagnosis
    Arm Type
    Experimental
    Arm Description
    radiologists interpretTransvaginal Ultrasound images with the help of Artificial Intelligence algorithm
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm
    Other Intervention Name(s)
    AI Enabled Transvaginal Ultrasound diagnosis
    Intervention Description
    AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer
    Primary Outcome Measure Information:
    Title
    diagnostic accuracy
    Description
    diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    time cost for Transvaginal Ultrasound image interpretation
    Description
    time cost for radiologists to interpret Transvaginal Ultrasound images
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women scheduled for Transvaginal Ultrasound examination for adnexal lesions; Women aged over 18 years old; Women willing to participant in this study evidenced by signing the informed consent. Exclusion Criteria: Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa; Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination; Women with mental abnormal; Women did not cooperate or participate in other clinical trials; Pregnant or lactating women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qinglei Gao, MD, PhD
    Phone
    13871127473
    Ext
    13871127473
    Email
    qingleigao@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ding Ma, MD, PhD
    Phone
    13886090620
    Ext
    13886090620
    Email
    dingma424@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qinglei Gao, MD, PhD
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    contact Prof. Gao for detailed study protocol or data after the study completed by e-mail
    IPD Sharing Time Frame
    6 months after the study completed
    IPD Sharing Access Criteria
    all investigators in this study field can contact Prof. Gao for access by e-mail

    Learn more about this trial

    Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm

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