The Digital Breast Tomosynthesis Trial in Bergen

NCT ID: NCT02835625

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-05-31

Brief Summary

Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.

Detailed Description

DBT is a new screening tool, argued to be better than standard DM. This statement is based on a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have so far reported results from women screened with DBT from GE Healthcare, as far as the investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT data (SM), and studies have shown similar detection rates for this technique as of adjacent DM. By comparing results of early performance measures and economic aspects in two comparable populations of women in the same age group, residing in the same county, the investigators can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The populations will be examined by the same radiographers, screen-read by the same radiologists, histologically breast cancer proven by the same pathologists, and treated by the same surgeons and oncologists.

A prospective cohort study targeting 45,000 women invited to breast cancer screening in Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening participation of approximately 75% is expected. All attending women will be asked if they are willing to participate in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent. Of the attending women it is expected that about 90-95% will consent to participate in the study. The women will be randomized into two groups, a study group and a control group. The randomization will take place at the screening unit in Bergen. The outcome of the randomization is based on the 11-digit personal identification number assigned to every citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control group, the women will be screened with DM. Women not willing to participate in the study will be screened with DM, and not included in our study.

The investigators aim to address the following topics and research questions:

• Study 1: Early performance measures in a population based screening program using SM+DBT versus DM - interim analyses.
• Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized controlled trial.
• Study 3: Prognostic and predictive histopathologic characteristics of breast tumors detected in a population based program using SM+DBT versus DM.
• Study 4: SM+DBT and DM in a populations based screening program - which technology has the highest sensitivity for women with mammographic dense breast?
• Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is SM+DBT cost-effective?

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Digital Breast Tomosynthesis

Synthetic Mammography (SM) + Digital Breast Tomosynthesis (DBT)

The SM+DBT will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Women selected for further assessment (positive screening exam) will be recalled.

Group Type: ACTIVE_COMPARATOR

Synthetic Mammography + Digital Breast Tomosynthesis

Intervention Type: RADIATION

Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.

Digital mammography

The digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

Group Type: ACTIVE_COMPARATOR

Digital mammography

Intervention Type: RADIATION

Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Interventions

Synthetic Mammography + Digital Breast Tomosynthesis

Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.

Intervention Type: RADIATION

Digital mammography

Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Intervention Type: RADIATION

Other Intervention Names

SM+DBT; DM

Eligibility Criteria

Inclusion Criteria

• Informed consent

Exclusion Criteria

• Breast implants

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Solveig Hofvind, Professor

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

Haukeland University Hospital

Bergen, Hordaland, Norway

Cancer Registry of Norway

Oslo, , Norway

Countries

Norway

References

Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.

Reference Type: BACKGROUND

PMID: 23297332 (View on PubMed)

Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fanto C, Valentini M, Montemezzi S, Macaskill P. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. Lancet Oncol. 2013 Jun;14(7):583-9. doi: 10.1016/S1470-2045(13)70134-7. Epub 2013 Apr 25.

Reference Type: BACKGROUND

PMID: 23623721 (View on PubMed)

Lang K, Andersson I, Rosso A, Tingberg A, Timberg P, Zackrisson S. Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmo Breast Tomosynthesis Screening Trial, a population-based study. Eur Radiol. 2016 Jan;26(1):184-90. doi: 10.1007/s00330-015-3803-3. Epub 2015 May 1.

Reference Type: BACKGROUND

PMID: 25929946 (View on PubMed)

Haas BM, Kalra V, Geisel J, Raghu M, Durand M, Philpotts LE. Comparison of tomosynthesis plus digital mammography and digital mammography alone for breast cancer screening. Radiology. 2013 Dec;269(3):694-700. doi: 10.1148/radiol.13130307. Epub 2013 Oct 28.

Reference Type: BACKGROUND

PMID: 23901124 (View on PubMed)

Durand MA, Haas BM, Yao X, Geisel JL, Raghu M, Hooley RJ, Horvath LJ, Philpotts LE. Early clinical experience with digital breast tomosynthesis for screening mammography. Radiology. 2015 Jan;274(1):85-92. doi: 10.1148/radiol.14131319. Epub 2014 Sep 1.

Reference Type: BACKGROUND

PMID: 25188431 (View on PubMed)

Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, Hayes MK, Copit DS, Carlson KL, Cink TM, Barke LD, Greer LN, Miller DP, Conant EF. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507. doi: 10.1001/jama.2014.6095.

Reference Type: BACKGROUND

PMID: 25058084 (View on PubMed)

Rose SL, Tidwell AL, Bujnoch LJ, Kushwaha AC, Nordmann AS, Sexton R Jr. Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol. 2013 Jun;200(6):1401-8. doi: 10.2214/AJR.12.9672.

Reference Type: BACKGROUND

PMID: 23701081 (View on PubMed)

McCarthy AM, Kontos D, Synnestvedt M, Tan KS, Heitjan DF, Schnall M, Conant EF. Screening outcomes following implementation of digital breast tomosynthesis in a general-population screening program. J Natl Cancer Inst. 2014 Oct 13;106(11):dju316. doi: 10.1093/jnci/dju316. Print 2014 Nov.

Reference Type: BACKGROUND

PMID: 25313245 (View on PubMed)

Greenberg JS, Javitt MC, Katzen J, Michael S, Holland AE. Clinical performance metrics of 3D digital breast tomosynthesis compared with 2D digital mammography for breast cancer screening in community practice. AJR Am J Roentgenol. 2014 Sep;203(3):687-93. doi: 10.2214/AJR.14.12642. Epub 2014 Jun 11.

Reference Type: BACKGROUND

PMID: 24918774 (View on PubMed)

Lourenco AP, Barry-Brooks M, Baird GL, Tuttle A, Mainiero MB. Changes in recall type and patient treatment following implementation of screening digital breast tomosynthesis. Radiology. 2015 Feb;274(2):337-42. doi: 10.1148/radiol.14140317. Epub 2014 Sep 22.

Reference Type: BACKGROUND

PMID: 25247407 (View on PubMed)

Destounis S, Arieno A, Morgan R. Initial experience with combination digital breast tomosynthesis plus full field digital mammography or full field digital mammography alone in the screening environment. J Clin Imaging Sci. 2014 Feb 25;4:9. doi: 10.4103/2156-7514.127838. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24744966 (View on PubMed)

Skaane P, Bandos AI, Eben EB, Jebsen IN, Krager M, Haakenaasen U, Ekseth U, Izadi M, Hofvind S, Gullien R. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63. doi: 10.1148/radiol.13131391. Epub 2014 Jan 24.

Reference Type: BACKGROUND

PMID: 24484063 (View on PubMed)

Zuley ML, Guo B, Catullo VJ, Chough DM, Kelly AE, Lu AH, Rathfon GY, Lee Spangler M, Sumkin JH, Wallace LP, Bandos AI. Comparison of two-dimensional synthesized mammograms versus original digital mammograms alone and in combination with tomosynthesis images. Radiology. 2014 Jun;271(3):664-71. doi: 10.1148/radiol.13131530. Epub 2014 Jan 21.

Reference Type: BACKGROUND

PMID: 24475859 (View on PubMed)

Gilbert FJ, Tucker L, Gillan MG, Willsher P, Cooke J, Duncan KA, Michell MJ, Dobson HM, Lim YY, Suaris T, Astley SM, Morrish O, Young KC, Duffy SW. Accuracy of Digital Breast Tomosynthesis for Depicting Breast Cancer Subgroups in a UK Retrospective Reading Study (TOMMY Trial). Radiology. 2015 Dec;277(3):697-706. doi: 10.1148/radiol.2015142566. Epub 2015 Jul 15.

Reference Type: BACKGROUND

PMID: 26176654 (View on PubMed)

Houssami N, Skaane P. Overview of the evidence on digital breast tomosynthesis in breast cancer detection. Breast. 2013 Apr;22(2):101-108. doi: 10.1016/j.breast.2013.01.017. Epub 2013 Feb 16.

Reference Type: BACKGROUND

PMID: 23422255 (View on PubMed)

Bonafede MM, Kalra VB, Miller JD, Fajardo LL. Value analysis of digital breast tomosynthesis for breast cancer screening in a commercially-insured US population. Clinicoecon Outcomes Res. 2015 Jan 12;7:53-63. doi: 10.2147/CEOR.S76167. eCollection 2015.

Reference Type: BACKGROUND

PMID: 25624767 (View on PubMed)

Lee CI, Cevik M, Alagoz O, Sprague BL, Tosteson AN, Miglioretti DL, Kerlikowske K, Stout NK, Jarvik JG, Ramsey SD, Lehman CD. Comparative effectiveness of combined digital mammography and tomosynthesis screening for women with dense breasts. Radiology. 2015 Mar;274(3):772-80. doi: 10.1148/radiol.14141237. Epub 2014 Oct 28.

Reference Type: BACKGROUND

PMID: 25350548 (View on PubMed)

Moger TA, Bjornelv GM, Aas E. Expected 10-year treatment cost of breast cancer detected within and outside a public screening program in Norway. Eur J Health Econ. 2016 Jul;17(6):745-54. doi: 10.1007/s10198-015-0719-4. Epub 2015 Aug 4.

Reference Type: BACKGROUND

PMID: 26239280 (View on PubMed)

Tingberg A, Zackrisson S. Digital mammography and tomosynthesis for breast cancer diagnosis. Expert Opin Med Diagn. 2011 Nov;5(6):517-26. doi: 10.1517/17530059.2011.616492. Epub 2011 Sep 6.

Reference Type: BACKGROUND

PMID: 23484749 (View on PubMed)

Aase HS, Holen AS, Pedersen K, Houssami N, Haldorsen IS, Sebuodegard S, Hanestad B, Hofvind S. A randomized controlled trial of digital breast tomosynthesis versus digital mammography in population-based screening in Bergen: interim analysis of performance indicators from the To-Be trial. Eur Radiol. 2019 Mar;29(3):1175-1186. doi: 10.1007/s00330-018-5690-x. Epub 2018 Aug 29.

Reference Type: RESULT

PMID: 30159620 (View on PubMed)

Hofvind S, Holen AS, Aase HS, Houssami N, Sebuodegard S, Moger TA, Haldorsen IS, Akslen LA. Two-view digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening programme (To-Be): a randomised, controlled trial. Lancet Oncol. 2019 Jun;20(6):795-805. doi: 10.1016/S1470-2045(19)30161-5. Epub 2019 May 8.

Reference Type: RESULT

PMID: 31078459 (View on PubMed)

Moger TA, Swanson JO, Holen AS, Hanestad B, Hofvind S. Cost differences between digital tomosynthesis and standard digital mammography in a breast cancer screening programme: results from the To-Be trial in Norway. Eur J Health Econ. 2019 Nov;20(8):1261-1269. doi: 10.1007/s10198-019-01094-7. Epub 2019 Aug 9.

Reference Type: RESULT

PMID: 31399773 (View on PubMed)

Waade GG, Holen A, Sebuodegard S, Aase H, Pedersen K, Hanestad B, Hofvind S. Breast compression parameters among women screened with standard digital mammography and digital breast tomosynthesis in a randomized controlled trial. Acta Radiol. 2020 Mar;61(3):321-330. doi: 10.1177/0284185119863989. Epub 2019 Jul 25. No abstract available.

Reference Type: RESULT

PMID: 31342757 (View on PubMed)

Moshina N, Aase HS, Danielsen AS, Haldorsen IS, Lee CI, Zackrisson S, Hofvind S. Comparing Screening Outcomes for Digital Breast Tomosynthesis and Digital Mammography by Automated Breast Density in a Randomized Controlled Trial: Results from the To-Be Trial. Radiology. 2020 Dec;297(3):522-531. doi: 10.1148/radiol.2020201150. Epub 2020 Sep 15.

Reference Type: RESULT

PMID: 32930649 (View on PubMed)

Aase HS, Danielsen AS, Hoff SR, Holen AS, Haldorsen IS, Hovda T, Hanestad B, Sandvik CK, Hofvind S. Mammographic features and screening outcome in a randomized controlled trial comparing digital breast tomosynthesis and digital mammography. Eur J Radiol. 2021 Aug;141:109753. doi: 10.1016/j.ejrad.2021.109753. Epub 2021 May 5.

Reference Type: RESULT

PMID: 34053786 (View on PubMed)

Hofvind S, Moshina N, Holen AS, Danielsen AS, Lee CI, Houssami N, Aase HS, Akslen LA, Haldorsen IS. Interval and Subsequent Round Breast Cancer in a Randomized Controlled Trial Comparing Digital Breast Tomosynthesis and Digital Mammography Screening. Radiology. 2021 Jul;300(1):66-76. doi: 10.1148/radiol.2021203936. Epub 2021 May 11.

Reference Type: RESULT

PMID: 33973840 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

247941/H10

Identifier Type: -

Identifier Source: org_study_id