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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| University of Oslo | OTHER |
| The Research Council of Norway | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Mammography + Digital Breast Tomosynthesis | Radiation | Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mammographic Features of Screen-Detected Breast Cancer |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Solveig Hofvind, Professor | Norwegian Institute of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Hordaland | 0521 | Norway | ||
| Cancer Registry of Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23297332 | Background | 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. | |
| 23623721 |
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We will not share the data outside the project group
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Women that attended screening but had breast implant were not invited to participate, and thus not randomized to either of the study groups.
Women were invited to participate when attending screening at the screening unit Danmarksplass in Bergen, Norway. The recruitment period lasted from January 14th 2016 to December 15th 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Breast Tomosynthesis | Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. |
| FG001 | Digital Mammography | The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We excluded women with previous breast cancer (DBT = 314, DM = 316), women with breast symptoms at screening (DBT = 39, DM = 34) and one woman with metastasis from melanoma (DBT).
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Breast Tomosynthesis | Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 36 months from start up of the trial |
|
Participant were followed for two years after the recruitment period for the study ended (December 31st 2017) to collect data on adverse events. Reporting of adverse events are not yet complete as we rely on data from the Norwegian Cause of Death Registry.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Breast Tomosynthesis | Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Solveig Hofvind | Cancer Registry of Norway | +47 22928828 | solveig.hofvind@kreftregisteret.no |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2015 | May 8, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Digital mammography | Radiation | Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis. |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| Oslo |
| 0379 |
| Norway |
| 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. |
| 25929946 | 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. |
| 23901124 | 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. |
| 25188431 | 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. |
| 25058084 | 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. |
| 23701081 | 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. |
| 25313245 | 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. |
| 24918774 | 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. |
| 25247407 | 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. |
| 24744966 | 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. |
| 24484063 | 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. |
| 24475859 | 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. |
| 26176654 | 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. |
| 23422255 | 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. |
| 25624767 | 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. |
| 25350548 | 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. |
| 26239280 | 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. |
| 23484749 | 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. |
| 30159620 | Result | 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. |
| 31078459 | 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. |
| 31399773 | 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. |
| 31342757 | 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. |
| 32930649 | 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. |
| 34053786 | 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. |
| 33973840 | 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. |
| BG001 | Digital Mammography | The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Screening history | Count of Participants | Participants |
|
The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis. |
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | For each participant, the incremental cost of tomosynthesis vs. digital mammography were estimated, not the total cost of tomosynthesis vs. digital mammography. The investigators assumed that costs not pertaining to examination and reading times, mammograph price, IT storage and connectivity were equal for the two. This Outcome Measure was pre-specified to present the incremental costs per screened woman. By nature, incremental costs are calculated between groups. | Posted | Mean | 95% Confidence Interval | € | 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. | When collecting information on histopathological tumor characteristics, not all participants had information available on all variables. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 60 months from start up of the trial |
|
|
|
| Other Pre-specified | Time Spent on Screen-Reading and Consensus Meetings | The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography | Interim analysis performed on study population from the first year of the trial (2016). All cases were screen-read by two radiologist, however not all were discussed at consensus. | Posted | Mean | Standard Deviation | seconds | 24 months from start up of the trial |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 36 months from start up of the trial |
|
|
|
| Other Pre-specified | 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). | Interim analysis performed on study population from the first year of the trial (2016). Not all women had available information on radiation dose. | Posted | Mean | Standard Deviation | mGy | 24 months from start up of the trial |
|
|
|
| 2 |
| 14,734 |
| 0 |
| 14,734 |
| 0 |
| 14,734 |
| EG001 | Digital Mammography | The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis. | 2 | 14,719 | 0 | 14,719 | 0 | 14,719 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| Histological type : Lobular carcinoma |
|
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| Histological type : Tubular carcinoma |
|
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| Histological type : Other carcinoma |
|
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| Tumor diameter : <10 mm |
|
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| Tumor diameter : >=10-<20 mm |
|
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| Tumor diameter : >=20 mm |
|
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| Lymph node positive |
|
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| Histological grade : grade 1 |
|
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| Histological grade : grade 2 |
|
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| Histological grade : grade 3 |
|
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| Estrogen receptor positive |
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| Progesterone receptor positive |
|
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| HER2 positive |
|
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| Ki67 >=30% |
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| Consensus reading |
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| Calcifications |
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| Architectural distortion |
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| Asymmetry |
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| Mass with calcifications |
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| Circumscribed mass |
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| Obscured mass |
|
| Associated features |
|