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Diagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies


- candidate number28742
- NTR NumberNTR7197
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2018
- Secondary IDsNL61243.041.17 METC UMC Utrecht
- Public TitleDiagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies
- Scientific TitleDiagnostic value of three-dimensional ultrasound in breast cancer screening participants referred with a BI-RADS 0 test result: a comparison of imaging strategies
- ACRONYMTURB0
- hypothesisAddition of threedimensional breast ultrasound to the conventional diagnostic workup improves diagnostic accuracy in women referred from breast cancer screening with a BI-RADS 0 test result.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Mamma carcinoma, Ultrasound, Breast Ultrasonography
- Inclusion criteria- Dutch breast cancer screening participants aged 50-75 years
- BI-RADS 0 screening mammography result
- Referred to one of the participating hospitals for diagnostic work-up
- Exclusion criteria- Subject is unable to understand, read and sign the study specific informed consent after the nature of the study has been fully explained to her.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-mrt-2018
- planned closingdate1-apr-2020
- Target number of participants600
- InterventionsAddition of a bilateral threedimensional breast ultrasound to the conventional diagnostic workup of breast cancer screening participants referred with a BI-RADS 0 test result.
- Primary outcomeThe primary outcome is the accuracy of different imaging strategies in diagnosing breast cancer, expressed as the area under the receiver operating characteristic (ROC) curve. Pathology or the results of all imaging modalities are used as the reference standard. All study participants will be followed up to the next scheduled screening round approximately 2 years later to determine if any breast cancer was missed. The imaging modalities under study, supplemental to the full-field digital screening mammography, are 3DUS, digital breast tomosynthesis and handheld ultrasound.
- Secondary outcomeSecondary outcomes include the diagnostic accuracy of the different imaging studies for subgroups of patients based on age and mammographic density. Furthermore, the biopsy referral rate for the different imaging strategies and the interobserver reliability for 3DUS will be determined.
- TimepointsAll imaging is performed when the patient visits the hospital after referral from breast cancer screening with a BI-RADS 0 test result. Patients are followed up to the next scheduled screening round (approximately 2 years later) to determine if any breast cancer was missed.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD candidate B.M. Dekker, den
- CONTACT for SCIENTIFIC QUERIESMD PhD candidate B.M. Dekker, den
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
General Electric Healthcare
- Publications
- Brief summaryPopulation-based mammography screening has proven successful in decreasing breast cancer mortality due to breast cancer detection and treatment at an early stage. However, one of the main disadvantages of screening is a false-positive test result, leading to a costly diagnostic work-up of a non-malignant lesion, adverse psychological consequences and pressure on health care facilities, especially when an additional biopsy is necessary. In 2014 17,7 per 1000 women screened received a false positive result, in almost one third of these women (32.2%) invasive assessment was necessary. The highest percentage of non-malignant biopsies has been observed among the participants referred with a BI-RADS 0 result, the latter group representing 60% of all referrals. Therefore, the need for improvement of the supplemental imaging strategy, leading to the smallest number of biopsy referrals without missing any cancers, is most urgent among screening participants with a BI-RADS 0 test result.

Three-dimensional ultrasound (3DUS), a new imaging technique that enables the acquisition of volumetric images of the whole breast, is likely to play a major role in this improvement. Several studies have been performed on the diagnostic accuracy of 3DUS, showing promising results. However, the lesion detection, reliability and interobserver variability needs to be confirmed before this technique is implemented in the imaging strategy for BI-RADS 0 referrals. Therefore, the proposed multicenter diagnostic study aims to investigate the diagnostic value of 3DUS, as a standalone imaging modality as well as in combination with conventional imaging modalities, to diagnose breast cancer in Dutch breast cancer screening participants with a BI-RADS 0 mammography result. The primary outcome is the accuracy of different imaging strategies in diagnosing breast cancer, expressed as the area under the receiver operating characteristic curve. Pathology or the results of all imaging modalities are used as the reference standard. Follow up imaging of all study participants up to 2 years after inclusion will be checked for any breast cancer cases that were missed. The imaging modalities under study, supplemental to the full-field digital screening mammography, are 3DUS, digital breast tomosynthesis and handheld ultrasound.
- Main changes (audit trail)
- RECORD27-mrt-2018 - 13-mei-2018


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