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.
COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2012-08-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implementing Myocardial Computed Tomographic Perfusion in a Community Hospital Setting
NCT02756234
Instrument Precision Study for Validation of Philips Dx
NCT02699970
Clinical Readiness Skin Punch Biopsy Sample Collections
NCT06588426
Electromagnetic Tracking of Devices During Interventional Procedures
NCT01279148
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
NCT01750203
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.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Koning Breast CT - guided Biopsy
Koning Breast CT-guided Biopsy
The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Koning Breast CT-guided Biopsy
The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Lesion seen on mammography
* Diagnostic report read as BI-RADS 4 or 5
* Will undergo biopsy no later than four weeks from date of mammogram
* Is able to undergo informed consent
Exclusion Criteria
* Lactation
* Subjects with breast implants
* Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.
* Subjects who are unable to tolerate study constraints.
* Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
* Treatment for enlarged thymus gland as an infant
* Irradiation for benign breast conditions, including breast inflammation after giving birth
* Treatment for Hodgkins disease
* Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
* Tuberculosis
* Severe scoliosis
35 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elizabeth Wende Breast Care, LLC
OTHER
Koning Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Elizabeth Wende Breast Care
Rochester, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XWH-09-1-0441
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KBCT-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.