Artificial Intelligence in Breast Cancer Screening in Region Östergötland Linkoping

NCT ID: NCT05048095

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-02-15

Brief Summary

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The purpose of this observational study is to assess whether the use of AI (Transpara®) can lead to an improved quality of a double reading mammography screening program. This is investigated by performing AI as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without AI).

Detailed Description

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The AI cancer detection system will act as a 3rd reader and will recall additional cases to the consensus conference: the exams that were not recalled by double reading but are classified as the 3% most suspicious exams, based on AI derived cancer-risk scores. Secondly, AI is used as a decision support during consensus. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and soft tissue lesions are provided to the reader(s).

The hypothesis of this study is that the use of AI has the potential to improve the quality of the screening program by increasing the cancer detection rate without affecting the recall rate.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screened women in Region Östergötland Linkoping

AI cancer detection system

Intervention Type OTHER

The use of AI as a third reader and as a decision support system during consensus meeting

Interventions

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AI cancer detection system

The use of AI as a third reader and as a decision support system during consensus meeting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women participating in the regular Breast Cancer Screening Program in Region Östergötland Linkoping

Exclusion Criteria

* Women with breast implants or other foreign implants in the mammogram
* Women with symptoms or signs of suspected breast cancer
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ostergotland County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Håkan Gustafsson

Adjunct Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Håkan Gustafsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linköping University - University Hospital

Locations

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Region Östergötland

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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Rodriguez-Ruiz A, Lang K, Gubern-Merida A, Broeders M, Gennaro G, Clauser P, Helbich TH, Chevalier M, Tan T, Mertelmeier T, Wallis MG, Andersson I, Zackrisson S, Mann RM, Sechopoulos I. Stand-Alone Artificial Intelligence for Breast Cancer Detection in Mammography: Comparison With 101 Radiologists. J Natl Cancer Inst. 2019 Sep 1;111(9):916-922. doi: 10.1093/jnci/djy222.

Reference Type BACKGROUND
PMID: 30834436 (View on PubMed)

Rodriguez-Ruiz A, Krupinski E, Mordang JJ, Schilling K, Heywang-Kobrunner SH, Sechopoulos I, Mann RM. Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System. Radiology. 2019 Feb;290(2):305-314. doi: 10.1148/radiol.2018181371. Epub 2018 Nov 20.

Reference Type BACKGROUND
PMID: 30457482 (View on PubMed)

van Winkel SL, Rodriguez-Ruiz A, Appelman L, Gubern-Merida A, Karssemeijer N, Teuwen J, Wanders AJT, Sechopoulos I, Mann RM. Impact of artificial intelligence support on accuracy and reading time in breast tomosynthesis image interpretation: a multi-reader multi-case study. Eur Radiol. 2021 Nov;31(11):8682-8691. doi: 10.1007/s00330-021-07992-w. Epub 2021 May 4.

Reference Type BACKGROUND
PMID: 33948701 (View on PubMed)

Pinto MC, Rodriguez-Ruiz A, Pedersen K, Hofvind S, Wicklein J, Kappler S, Mann RM, Sechopoulos I. Impact of Artificial Intelligence Decision Support Using Deep Learning on Breast Cancer Screening Interpretation with Single-View Wide-Angle Digital Breast Tomosynthesis. Radiology. 2021 Sep;300(3):529-536. doi: 10.1148/radiol.2021204432. Epub 2021 Jul 6.

Reference Type BACKGROUND
PMID: 34227882 (View on PubMed)

Raya-Povedano JL, Romero-Martin S, Elias-Cabot E, Gubern-Merida A, Rodriguez-Ruiz A, Alvarez-Benito M. AI-based Strategies to Reduce Workload in Breast Cancer Screening with Mammography and Tomosynthesis: A Retrospective Evaluation. Radiology. 2021 Jul;300(1):57-65. doi: 10.1148/radiol.2021203555. Epub 2021 May 4.

Reference Type BACKGROUND
PMID: 33944627 (View on PubMed)

Lang K, Dustler M, Dahlblom V, Akesson A, Andersson I, Zackrisson S. Identifying normal mammograms in a large screening population using artificial intelligence. Eur Radiol. 2021 Mar;31(3):1687-1692. doi: 10.1007/s00330-020-07165-1. Epub 2020 Sep 2.

Reference Type BACKGROUND
PMID: 32876835 (View on PubMed)

Rodriguez-Ruiz A, Lang K, Gubern-Merida A, Teuwen J, Broeders M, Gennaro G, Clauser P, Helbich TH, Chevalier M, Mertelmeier T, Wallis MG, Andersson I, Zackrisson S, Sechopoulos I, Mann RM. Can we reduce the workload of mammographic screening by automatic identification of normal exams with artificial intelligence? A feasibility study. Eur Radiol. 2019 Sep;29(9):4825-4832. doi: 10.1007/s00330-019-06186-9. Epub 2019 Apr 16.

Reference Type BACKGROUND
PMID: 30993432 (View on PubMed)

Lang K, Hofvind S, Rodriguez-Ruiz A, Andersson I. Can artificial intelligence reduce the interval cancer rate in mammography screening? Eur Radiol. 2021 Aug;31(8):5940-5947. doi: 10.1007/s00330-021-07686-3. Epub 2021 Jan 23.

Reference Type BACKGROUND
PMID: 33486604 (View on PubMed)

Sasaki M, Tozaki M, Rodriguez-Ruiz A, Yotsumoto D, Ichiki Y, Terawaki A, Oosako S, Sagara Y, Sagara Y. Artificial intelligence for breast cancer detection in mammography: experience of use of the ScreenPoint Medical Transpara system in 310 Japanese women. Breast Cancer. 2020 Jul;27(4):642-651. doi: 10.1007/s12282-020-01061-8. Epub 2020 Feb 12.

Reference Type BACKGROUND
PMID: 32052311 (View on PubMed)

Kerschke L, Weigel S, Rodriguez-Ruiz A, Karssemeijer N, Heindel W. Using deep learning to assist readers during the arbitration process: a lesion-based retrospective evaluation of breast cancer screening performance. Eur Radiol. 2022 Feb;32(2):842-852. doi: 10.1007/s00330-021-08217-w. Epub 2021 Aug 12.

Reference Type BACKGROUND
PMID: 34383147 (View on PubMed)

Other Identifiers

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NCT20210157-AI-ROL

Identifier Type: -

Identifier Source: org_study_id

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