- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838756
Mammography Screening With Artificial Intelligence (MASAI) (MASAI)
A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skane
-
Malmö, Skane, Sweden, 20550
- Mammography Unit, Unilabs/Skane University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Women eligible for population-based mammography screening.
Exclusion Criteria:
None.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
AI-integrated mammography screening
|
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.
|
Experimental: Control arm
Conventional mammography screening (standard of care)
|
Screen exams will be read by two radiologists without the support of AI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interval-cancer rate
Time Frame: 43 months
|
Women with interval cancer per 1000 screens
|
43 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer-detection rate
Time Frame: 15 months
|
Women with screen-detected cancer per 1000 screens
|
15 months
|
Recall rate
Time Frame: 15 months
|
Number of recalls per 1000 screens
|
15 months
|
False-positive rate
Time Frame: 15 months
|
Women with false positive per 1000 screens
|
15 months
|
Positive Predictive Value-1
Time Frame: 15 months
|
Women with cancer for all recalls
|
15 months
|
Sensitivity and specificity
Time Frame: 43 months
|
True and false-positive rate
|
43 months
|
Cancer detection per cancer type
Time Frame: 19 months
|
Screen detection of cancer in relation to cancer type, size and stage
|
19 months
|
Tumour biology of interval cancers
Time Frame: 43 months
|
Characterization of interval cancers per type, size and stage
|
43 months
|
Screen-reading workload
Time Frame: 19 months
|
Number of screen-readings and number of consensus meetings
|
19 months
|
Incremental cost-effectiveness ratio
Time Frame: 43 months
|
The incremental cost-effectiveness ratio for AI-integrated mammography screening versus standard of care
|
43 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristina Lång, MD PhD, Region Skane
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020-04936
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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