DLSCT for Breast Cancer Detection in Women With Dense Breasts
NCT ID: NCT05181059
Last Updated: 2022-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
14 participants
OBSERVATIONAL
2022-01-01
2023-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography
NCT01593384
Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women
NCT02209129
Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial
NCT01315015
Early Detection of Breast Cancer Using Tomosynthesis Imaging
NCT00637598
Breast MRI as a Preoperative Tool for DCIS
NCT00605982
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dual-layer spectral computerized tomography (DLSCT)
Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Tumors \> 5 cm (= T3) or
2. Tumors with invasion of the skin or chest wall (= T4) or
3. Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
* Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Exclusion Criteria
* Pregnancy or breast feeding
* Treatment of thyroid disease with radioactive iodine
* Use of metformin
* Creatinine clearance \< 45 ml/min
* Chronic or acutely worsening renal disease
* Patients who are declared incompetent
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rijnstate Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura N Deden
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Maxime V.P. Schyns, MD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rijnstate Hospital
Arnhem, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL76792.091.21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.