|- candidate number||27506|
|- NTR Number||NTR6589|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2017|
|- Secondary IDs||843001801 ZonMw|
|- Public Title||Rapid access to contrast mammography for women recalled from breast cancer screening|
|- Scientific Title||Rapid Access to Contrast-Enhanced spectral mammogRaphy (RACER): a more efficient work-up of women recalled from breast cancer screening|
|- hypothesis||Rapid access to CESM is more accurate, more patient-friendly and less expensive than usual care, which is based on current national guidelines on breast cancer.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Mammography, Breast cancer screening|
|- Inclusion criteria||Included are women able to provide informed consent and recalled from breast cancer screening during the 18-month study period.|
|- Exclusion criteria||Exclusion criteria are contra-indications for the use of iodine-based contrast agents (allergies), severe renal insufficiency or risk for contrast-induced nephropathy|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||29-dec-2017|
|- planned closingdate||29-dec-2021|
|- Target number of participants||528|
|- Interventions||Rapid access to CESM and further work-up of the recalled breast abnormality based on CESM-findings. In CESM, an iodine based contrast agent is injected two minutes prior to image acquisition. Next, standard mammography views will be performed with dual-energy mammography. These will provide the radiologist with two images per exposure: one similar to a mammogram, one containing information on contrast enhancement. Previous studies showed that no radiological training is required for CESM. Regular (mandatory) study monitoring at the participating centers will be used to check adherence to the study protocol.|
|- Primary outcome||Primary diagnostic performance of CESM as compared to mammography, defined as
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), area under the ROC curve (AUC)|
|- Secondary outcome||Days to final diagnosis for both study arms; Patient experienced anxiety (as measured by State-Trait Anxiety Inventory (STAI) and EQ5D questionnaires) for both approaches; cost-effectiveness and budget impact analysis;|
|- Timepoints||Start to month 3: study preparations, such as study logistics and acquiring final approval of the ethical committees (application will already be in process) – Month 3-21: inclusion of patients, with first analysis of diagnostic performance being performed after final inclusion - Month 21-45: follow-up period, in which interval carcinomas will be collected and analyzed, and first analyses of the experienced patient anxiety questionnaires – Month 45-48: final data analysis,
cost-effectiveness evaluation and initiation of the implementation strategy plan.|
|- Trial web site||Not available|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. M. Lobbes|
|- CONTACT for SCIENTIFIC QUERIES||MD. M. Lobbes|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZonMw Doelmatigheid, GE Healthcare, Maastricht University Medical Center, Department of Radiology and Nuclear Medicine|
|- Publications||Not yet available|
|- Brief summary||OBJECTIVE(S)/RESEARCH QUESTION(S): Does rapid access to CESM compared to conventional imaging result in a more accurate, a cost-effective and patient friendlier approach in women recalled from screening?|
STUDY DESIGN: Multicenter, randomized, controlled clinical trial.
STUDY POPULATION: Women recalled from the breast cancer screening program for a suspicious breast lesion.
INTERVENTION: Rapid access to CESM-based work-up of the breast lesion of interest.
USUAL CARE/COMPARISON: Lesion work-up using standard of care, which consist of more frequent patient visits (via general physician to nurse practitioner and/or surgeon) and conventional imaging using full-field digital mammography (FFDM).
OUTCOME MEASURES: Diagnostic performance parameters of usual care vs. CESM; experienced patient stress and anxiety; cost-effectiveness of both strategies; evaluation of the most efficient work-up strategy for an individual.
SAMPLE SIZE/DATA ANALYSIS: To enable detection of a relevant increase of specificity of 15% (mammography specificity being 40%), at a prevalence of 30% 251 patients need to be included in each study arm (power 80%, alpha 5%). Hence, the final population size (including 5% loss of data) will be 528. Data analysis includes evaluation of diagnostic performance of
each modality and a cost-effectiveness analysis of both strategies. An evaluation of experienced patient anxiety will be performed using validated questionnaires.
COST-EFFECTIVENESS ANALYSIS/BUDGET IMPACT ANALYSIS: A cost-utility analysis will be performed from a societal perspective. Resource use related to diagnostic testing and short term morbidity will be registered. Cost-prices will be derived from the Dutch guidelines for cost calculation or the hospital’s financial department. Health related anxiety and quality of life information will be collected. Incremental costs per QALY and life years saved will be calculated. A budget impact analysis will be performed from a health care budgetary and societal perspective. Input parameters will be based on this project, expert opinion and literature.
|- Main changes (audit trail)|
|- RECORD||6-jul-2017 - 1-apr-2018|