The Digital Breast Tomosynthesis Trial in Bergen

NCT02835625 | Completed Results

• 1 other identifier: 247941/H10
• Study Type: interventional
• Target: 29,453
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms

Keywords

Diagnostic Imaging; Mammography; Randomized Controlled Trial; Tomosynthesis; Early performance measures; Recall; Radiation dose; Cancer detection; Sensitivity; Specificity; Cost; Economy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Screen-Detected Breast Cancer

  Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.

  36 months from start up of the trial

Secondary Outcomes (5)

• Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment

  36 months from start up of the trial

• Number of Participants Recalled for Further Assesment Due to Mammographic Findings

  36 months from start up of the trial

• Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography

  36 months from start up of the trial

• Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer

  36 months from start up of the trial

• Number of Participants With Interval Breast Cancer

  60 months from start up of the trial

Other Outcomes (3)

• Time Spent on Screen-Reading and Consensus Meetings

  24 months from start up of the trial

• Mammographic Features of Screen-Detected Breast Cancer

  36 months from start up of the trial

• Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography

  24 months from start up of the trial

Study Arms (2)

Digital Breast Tomosynthesis

ACTIVE COMPARATOR

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.

Radiation: Synthetic Mammography + Digital Breast Tomosynthesis

Digital mammography

ACTIVE COMPARATOR

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

Radiation: Digital mammography

Interventions

Synthetic Mammography + Digital Breast Tomosynthesis RADIATION

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

Also known as: SM+DBT

Digital Breast Tomosynthesis

Digital mammography RADIATION

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

Also known as: DM

Digital mammography

Eligibility Criteria

• Age: 48 Years - 71 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent

You may not qualify if:

• Breast implants

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• Haukeland University Hospital: collaborator
• University of Oslo: collaborator
• The Research Council of Norway: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, Hordaland, 0521, Norway

Location

Cancer Registry of Norway

Oslo, 0379, Norway

Location

Related Publications (26)

• 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.

  PMID: 23297332 BACKGROUND

• 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.

  PMID: 23623721 BACKGROUND

• 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.

  PMID: 25929946 BACKGROUND

• 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.

  PMID: 23901124 BACKGROUND

• 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.

  PMID: 25188431 BACKGROUND

• 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.

  PMID: 25058084 BACKGROUND

• 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.

  PMID: 23701081 BACKGROUND

• 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.

  PMID: 25313245 BACKGROUND

• 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.

  PMID: 24918774 BACKGROUND

• 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.

  PMID: 25247407 BACKGROUND

• 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.

  PMID: 24744966 BACKGROUND

• 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.

  PMID: 24484063 BACKGROUND

• 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.

  PMID: 24475859 BACKGROUND

• 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.

  PMID: 26176654 BACKGROUND

• 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.

  PMID: 23422255 BACKGROUND

• 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.

  PMID: 25624767 BACKGROUND

• 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.

  PMID: 25350548 BACKGROUND

• 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.

  PMID: 26239280 BACKGROUND

• 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.

  PMID: 23484749 BACKGROUND

• 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.

  PMID: 30159620 RESULT

• 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.

  PMID: 31078459 RESULT

• 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.

  PMID: 31399773 RESULT

• 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.

  PMID: 31342757 RESULT

• 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.

  PMID: 32930649 RESULT

• 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.

  PMID: 34053786 RESULT

• 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.

  PMID: 33973840 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Results Point of Contact

• Title: Prof. Solveig Hofvind
• Organization: Cancer Registry of Norway

solveig.hofvind@kreftregisteret.no

+47 22928828

Study Officials

• Solveig Hofvind, Professor

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 18, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: May 1, 2021
• Last Updated: August 28, 2024
• Results First Posted: January 15, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)