Clinical trial · Interventional
Koning Breast Computed Tomography Guided Biopsy
Koning Breast CT-guided Biopsy Phase I Trial
NCT01750320CI-TRIAL-00031955completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Koning Breast CT-guided Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Koning Breast CT - guided Biopsy
- interventionNames
- Device: Koning Breast CT-guided Biopsy
Primary outcomes (1)
- measure
- The accuracy of Koning breast CT-guided biopsy
- timeFrame
- about 1 year
- description
- The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Female at least 35 years of age of any ethnicity * 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: * Pregnancy * 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
References
Publications (0)
Data not yet available
No reference posted for this study.