The Digital Breast Tomosynthesis Trial in Bergen

Breast Neoplasms Clinical Trial

— TOBE  

Official title:

Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835625
• Other study ID #: 247941/H10
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2021

Study information

• Verified date: January 2020
• Source: Cancer Registry of Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29453
• Est. completion date: May 2021
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 71 Years

Eligibility

Inclusion Criteria:

• Informed consent

Exclusion Criteria:

• Breast implants

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Radiation:
• Synthetic Mammography + Digital Breast Tomosynthesis
Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.
• Digital mammography
Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland
Norway	Cancer Registry of Norway	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Cancer Registry of Norway	Haukeland University Hospital, The Research Council of Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (26)

Aase HS, Danielsen AS, Hoff SR, Holen ÅS, 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. — View Citation

Aase HS, Holen ÅS, Pedersen K, Houssami N, Haldorsen IS, Sebuødegård 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 performanc — View Citation

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. — View Citation

Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fantò 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hofvind S, Holen ÅS, Aase HS, Houssami N, Sebuødegård 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. L — View Citation

Hofvind S, Moshina N, Holen ÅS, 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. Radi — View Citation

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. Review. — View Citation

Lång 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 Malmö 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. — View Citation

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. — View Citation

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. — View Citation

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). pii: dju316. doi: 10.1093/jnci/dju316. Print 2014 Nov. — View Citation

Moger TA, Bjørnelv 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. — View Citation

Moger TA, Swanson JO, Holen ÅS, 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):1261-1 — View Citation

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 Tri — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Waade GG, Holen Å, Sebuødegård 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 — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time Spent on Screen-Reading and Consensus Meetings	The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography	24 months from start up of the trial
Other	Mammographic Features of Screen-Detected Breast Cancer	Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.	36 months from start up of the trial
Other	Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography	Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).	24 months from start up of the trial
Primary	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	Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment	Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.	36 months from start up of the trial
Secondary	Number of Participants Recalled for Further Assesment Due to Mammographic Findings	Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.	36 months from start up of the trial
Secondary	Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography	The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.	36 months from start up of the trial
Secondary	Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer	Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.	36 months from start up of the trial
Secondary	Number of Participants With Interval Breast Cancer	Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.	60 months from start up of the trial