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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06032390
Other study ID # 366405
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date June 2033

Study information

Verified date June 2023
Source Cancer Registry of Norway
Contact Solveig Hofvind, PhD
Phone 22928828
Email sshh@kreftregisteret.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this randomized controlled trial is to compare the number of breast cancers detected among women who had their screening mammograms interpreted by artificial intelligence (AI) in combination with one or two breast radiologists to the number of breast cancers detected after standard independent double reading in BreastScreen Norway. The aims of the study is to prove that screening interpretation with AI in combination with one or two radiologists (the intervention) is non-inferior to standard interpretation procedure.


Description:

Independent double reading with consensus is the recommended practice for breast cancer screening programs in Europe. This is a time-consuming process and more than 99% of examinations are determined to have a negative final outcome in BreastScreen Norway. However, radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected and interval cancers to be visible at prior screening mammograms. In Norway and other countries, there is also a shortage of breast radiologists. Retrospective studies on AI in mammographic screening have shown promising results in the classification of cancer negative and cancer positive examinations. However, prospective studies are needed to elucidate questions concerning AI as a support or replacement for the radiologists in the interpretation process. In this randomized controlled trial women attending screening and consenting to participate in the study, will be randomized (1:1 allocation) to an intervention or a control group. The screening examination will be performed as usual in both groups. The intervention in the trial is the interpretation procedure. All examinations will be analyzed by AI. In the intervention group, examinations will be triaged according to risk of malignancy defined by an AI score. Examinations with a low AI score will have a single reading by one radiologist and examinations with a intermediate or high AI score will have an independent double reading by two radiologists. All examinations selected by either one or both radiologist will be discussed at consensus. Examinations with an AI raw score of 9.8 or above will be discussed at consensus independent of the radiologists' interpretation. The radiologists will be blinded to whether the mammograms are interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious calcifications and masses are only provided to the radiologists at consensus, not during independent reading. In the control group, two independent radiologists will interpret all screening examinations according to standard procedure, independent double reading. AI results will not be available at either independent reading or consensus, only for comparison with the intervention group in final analyses. Screen-detected cancers in the intervention and control arm will be analyzed in terms of non-inferiority.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150000
Est. completion date June 2033
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 69 Years
Eligibility Inclusion Criteria: - Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent Exclusion Criteria: - Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent, or with breast implants

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AI assisted mammography screening interpretation
Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in consensus. Examinations with an AI score of 9.8 and above will be selected to consensus by default. Risk scores and AI image markings are provided to the readers only in consensus. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).
Standard mammography screening interpretation
Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in consensus, and the readers will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Cancer Registry of Norway Helse Midt-Norge, Helse Nord, Helse Vest, Norwegian Cancer Society

Outcome

Type Measure Description Time frame Safety issue
Primary Screen-detected breast cancers Number of breast cancers detected at screening per 1000 screening examinations. 36 months from study start-up
Secondary Consensus rate Proportion of participant discussed in consensus among all participants (%). 24 months from study start-up
Secondary Recall rate Proportion of women recalled for further assessment among all participants (%). 24 months from study start-up
Secondary Interval breast cancers Number of interval breast cancers diagnosed per 1000 screening examinations. 60 months from study start-up
Secondary Prognostic and predictive tumor characteristics of screen-detected breast cancer Distribution of tumor characteristics among the participants with screen-detected breast cancer. 36 months from study start-up
Secondary Prognostic and predictive tumor characteristics of interval breast cancer Distribution of tumor characteristics among the participants with interval breast cancer. 60 months from study start-up
Secondary Sensitivity Proportion of true positives among true positive and false negatives (%). 60 months from study start-up
Secondary Specificity Proportion of true negatives among true negatives and false positives (%). 60 months from study start-up
Secondary Mammographic features of screen-detected breast cancer Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer. 36 months from study start-up
Secondary Time spent screen-reading Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms 36 months from study start-up
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