Breast NeoplasmsTOBENCT02835625
The Digital Breast Tomosynthesis Trial in Bergen
A study testing Synthetic Mammography + Digital Breast Tomosynthesis and Digital mammography in people with Breast Neoplasms, run by Norwegian Institute of Public Health at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 48 to 71 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Synthetic Mammography + Digital Breast Tomosynthesis and Digital mammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,453 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2016to May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 71 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
Who cannot join
- Breast implants
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, Hordaland, 0521
Cancer Registry of Norway
Oslo, 0379
About this study
Official title: Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
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.
Read the 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
- Being tested
- Synthetic Mammography + Digital Breast Tomosynthesis, Digital mammography
- Keywords
- Diagnostic Imaging, Mammography, Randomized Controlled Trial, Tomosynthesis, Early performance measures, Recall, Radiation dose, Cancer detection, Sensitivity, Specificity, Cost, Economy
- Medical subject headings
- Breast Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Mammography + Digital Breast TomosynthesisRadiation
Also called SM+DBT
Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.
Digital mammographyRadiation
Also called DM
Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Digital mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 36 months from start up of the trial
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 months from start up of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2018
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29,453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, University of Oslo, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Solveig Hofvind, Professor, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835625
- Sponsor's protocol ID
- 247941/H10
- Acronym
- TOBE
- Status last verified
- Jan 2020
- First submitted
- 23 Jun 2016
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: We will not share the data outside the project group
Publications
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.
PubMed 23297332Ciatto 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.
PubMed 23623721Lang 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.
PubMed 25929946Haas 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.
PubMed 23901124Durand 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.
PubMed 25188431Friedewald 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.
PubMed 25058084Rose 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.
PubMed 23701081McCarthy 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.
PubMed 25313245Greenberg 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.
PubMed 24918774Lourenco 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.
PubMed 25247407Destounis 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.
PubMed 24744966Skaane 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.
PubMed 24484063Zuley 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.
PubMed 24475859Gilbert 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.
PubMed 26176654Houssami 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.
PubMed 23422255
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
- ClinicalTrials.gov ID
- NCT02835625
- Acronym / sponsor ID
- TOBE / 247941/H10
- Conditions
- Breast Neoplasms
- Keywords
- Diagnostic Imaging, Mammography, Randomized Controlled Trial, Tomosynthesis, Early performance measures, Recall, Radiation dose, Cancer detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29,453 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- Haukeland University Hospital, University of Oslo, The Research Council of Norway
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Breast Tomosynthesis | Active comparator | Radiation: Synthetic Mammography + Digital Breast TomosynthesisSynthetic 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 | Radiation: Digital mammographyThe digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not. |
Who may qualify
- Ages
- 48 to 71 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent
Key exclusion criteria (1 listed)
- Breast implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic Mammography + Digital Breast TomosynthesisAlso: SM+DBTTwo-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis. | Radiation | Digital Breast Tomosynthesis |
| Digital mammographyAlso: DMTwo-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis. | Radiation | Digital mammography |
Primary outcome
Number of Participants With Screen-Detected Breast Cancer
Time frame: 36 months from start up of the trial
Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.
5 secondary outcomes
Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment
Time frame: 36 months from start up of the trial
Number of Participants Recalled for Further Assesment Due to Mammographic Findings
Time frame: 36 months from start up of the trial
Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
Time frame: 36 months from start up of the trial
Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
Time frame: 36 months from start up of the trial
Number of Participants With Interval Breast Cancer
Time frame: 60 months from start up of the trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23297332Skaane 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.
- Background: PubMed 23623721Ciatto 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.
- Background: PubMed 25929946Lang 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.
- Background: PubMed 23901124Haas 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.
- Background: PubMed 25188431Durand 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.
- Background: PubMed 25058084Friedewald 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.
- Background: PubMed 23701081Rose 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.
- Background: PubMed 25313245McCarthy 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.
- Background: PubMed 24918774Greenberg 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.
- Background: PubMed 25247407Lourenco 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.
- Background: PubMed 24744966Destounis 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.
- Background: PubMed 24484063Skaane 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.
- Individual participant dataSharing planned: No. We will not share the data outside the project group
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solveig Hofvind, Professor principal investigator
Norwegian Institute of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic Mammography + Digital Breast Tomosynthesis and Digital mammography in people with Breast Neoplasms, run by Norwegian Institute of Public Health at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Screen-Detected Breast Cancer (time frame: 36 months from start up of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835625, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.