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Mammography Screening With Artificial Intelligence (MASAI) (MASAI)

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ClinicalTrials.gov Identifier: NCT04838756
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborators:
Unilabs
Cancer Registry of Norway
Information provided by (Responsible Party):
Region Skane

Tracking Information
First Submitted Date  ICMJE April 6, 2021
First Posted Date  ICMJE April 9, 2021
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE April 12, 2021
Estimated Primary Completion Date November 12, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
Interval-cancer rate [ Time Frame: 43 months ]
Women with interval cancer per 1000 screens
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2021)
  • Cancer-detection rate [ Time Frame: 15 months ]
    Women with screen-detected cancer per 1000 screens
  • Recall rate [ Time Frame: 15 months ]
    Number of recalls per 1000 screens
  • False-positive rate [ Time Frame: 15 months ]
    Women with false positive per 1000 screens
  • Positive Predictive Value-1 [ Time Frame: 15 months ]
    Women with cancer for all recalls
  • Sensitivity and specificity [ Time Frame: 43 months ]
    True and false-positive rate
  • Cancer detection per cancer type [ Time Frame: 19 months ]
    Screen detection of cancer in relation to cancer type, size and stage
  • Tumour biology of interval cancers [ Time Frame: 43 months ]
    Characterization of interval cancers per type, size and stage
  • Screen-reading workload [ Time Frame: 19 months ]
    Number of screen-readings and number of consensus meetings
  • Incremental cost-effectiveness ratio [ Time Frame: 43 months ]
    The incremental cost-effectiveness ratio for AI-integrated mammography screening versus standard of care
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mammography Screening With Artificial Intelligence (MASAI)
Official Title  ICMJE A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study
Brief Summary The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI).
Detailed Description

European guidelines recommend that mammography exams in breast cancer screening are read by two breast radiologists to ensure a high sensitivity. Double reading is, however, resource demanding and still results in missed cancers. Computer-aided detection based on AI has been shown to have similar accuracy as an average breast radiologist. AI can be used as decision support by highlighting suspicious findings in the image as well as a means to triage screen exams according to risk of malignancy.

Eligible women will be randomized (1:1) to the intervention (AI-integrated mammography screening) or control arm (conventional mammography screening). In the intervention arm, exams will be analysed with AI and triaged into two groups based on risk of malignancy. Low risk exams will be single read and high risk exams will be double read. The high risk group will contain appx. 10% of the screening population. Within the high-risk group, exams with the highest 1% risk will by default be recalled by the readers with the exception of obvious false positives. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and masses are provided to the reader(s). In the control arm, screen exams are double read without AI (standard of care). Considering the interplay of number of interval cancers and workload, the study will be considered successful if the interval-cancer rate in the intervention arm is not more than 20% larger than in the control arm. If the interval-cancer rate is statistically and clinically significantly lower in the intervention arm than in the control arm, AI-integrated mammography screening will be considered superior to conventional mammography screening.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants have the possibility to opt-out. If they do not opt-out, neither the participant nor the nurse performing the screen exam will know to what study arm the participant was allocated. The radiologist reading the screen exam will however not be blinded to allocation information.
Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Other: AI screening modality
    Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives.
  • Other: Conventional screening modality
    Screen exams will be read by two radiologists without the support of AI.
Study Arms  ICMJE
  • Experimental: Intervention arm
    AI-integrated mammography screening
    Intervention: Other: AI screening modality
  • Experimental: Control arm
    Conventional mammography screening (standard of care)
    Intervention: Other: Conventional screening modality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 8, 2021)
100000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 12, 2025
Estimated Primary Completion Date November 12, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women eligible for population-based mammography screening.

Exclusion Criteria:

None.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04838756
Other Study ID Numbers  ICMJE 2020-04936
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD could be considered to be shared in future collaborations.
Responsible Party Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE
  • Unilabs
  • Cancer Registry of Norway
Investigators  ICMJE
Principal Investigator: Kristina Lång, MD PhD Region Skåne
PRS Account Region Skane
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP