Clinical trial · Observational
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions
Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions.
- 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 goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients with a breast lesion undergoing surgical biopsy. All patients will undergo stationary Carbon Nanotube x-ray digital breast tomosynthesis imaging in addition to routine conventional digital mammography.
- interventionNames
- Device: Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner
Primary outcomes (1)
- measure
- Receiver Operative Curve (ROC) Area Under the Curve (AUC) (percentage)
- timeFrame
- approximately 18 months
- description
- Receiver Operative Curve (ROC) Area Under the Curve (AUC) analysis of the stationary breast tomosynthesis (SDBT) system for the the characterization of suspicious breast lesions in comparison to x-ray mammography.
Secondary outcomes (1)
- measure
- Reader preference - arbitrary units
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women at least 18 years old. * Scheduled for breast biopsy of at least one breast lesion. * Lesion detected on mammogram. * Symptomatic by patient self-report, patient self-breast exam or clinical exam. * Able to provide informed consent. Exclusion Criteria: * Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents \<1% of newly diagnosed breast cancer) * Less than 18 years of age. * Patient unable to give consent. * Institutionalized subject (prisoner or nursing home patient). * Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating
References
Publications (1)
- BACKGROUNDQian X, Tucker A, Gidcumb E, Shan J, Yang G, Calderon-Colon X, Sultana S, Lu J, Zhou O, Spronk D, Sprenger F, Zhang Y, Kennedy D, Farbizio T, Jing Z. High resolution stationary digital breast tomosynthesis using distributed carbon nanotube x-ray source array. Med Phys. 2012 Apr;39(4):2090-9. doi: 10.1118/1.3694667. PMID 22482630