Clinical trial · Observational
Cone Beam Computed Tomography for Breast Imaging
NCT01107860CI-TRIAL-00010751completedClinicalTrials.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 continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
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 |
|---|---|---|---|
| Computed Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group I
- interventionNames
- Device: Computed Tomography
- label
- Group II
- interventionNames
- Device: Computed Tomography
Primary outcomes (1)
- measure
- Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology
- timeFrame
- about 3 years
- description
- The primary measure of this study will include the following aspects. * the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam * patient's comfort during the CBCT exam vs the mammographic exam * the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies * the concordance and discordance of CBCT breast imaging with histopathology * number of participants with adverse events as a measure of safety
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: Group I: * Females at least 35 years of age of any ethnicity * Had a mammogram, read as BI-RADS® 1 or 2 * Will undergo study imaging no later than four weeks from date of mammogram. * Is able to undergo informed consent. Group II: * Females at least 35 years of age of any ethnicity * Require diagnostic imaging * Will undergo study imaging no later than four weeks from date of diagnostic mammogram * Is able to undergo informed consent Exclusion Criteria: Group I and Group II: * Pregnancy * Lactation * Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * 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.