Clinical trial · Interventional
Evaluation of Breast CT
- 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 investigators have studied the potential of breast computed tomography (bCT) for breast imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10), and 4 breast CT scanners have been developed that have imaged over 600 women to date (under more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this (resubmitted) R01 grant application, the investigators seek to finalize the investigators' research in breast CT - The specific aims have been significantly modified as a result of the first critique, and the investigators now focus on a narrower set of remaining issues. This version of the protocol will add breast magnetic resonance imaging (MRI) to the experimental procedures.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Device | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast CT and Breast MRI
- description
- Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will undergo pre- and post- contrast breast computed tomography and pre- and post- contrast magnetic resonance imaging.
- interventionNames
- Device: computed tomography
- Device: MRI
Primary outcomes (1)
- measure
- Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.
- timeFrame
- 5 years
- description
- The specific quantitative endpoint of the analysis is the difference in area under the receiver operating characteristic curve (AUC) between contrast-enhanced breast CT (CE-bCT) and contrast-enhanced breast MRI (CE-bMRI).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Age at least 35 years old * Diagnostic findings from prior mammography highly suggestive of breast malignancy (BI- RADS® category 4 or BI-RADS® category 5) * Not pregnant or breast-feeding * Ability to lie motionless for up to 5 minutes Exclusion Criteria: * Recent breast biopsy * History of moderate or severe reaction to contrast agent injection * History of Allergy to Iodine * History of multiple food and/or drug allergy * Currently taking Glucophage or Glucovance (Metformin) * History of Chronic Asthma * History of Diabetes Mellitus * Renal (kidney) disease, or solitary kidney * Recent lab tests showing elevated serum creatinine (≥ 1.5 mg/dL) * Recent lab tests showing estimated glomerular filtration rate (eGFR) ≤ 60 ml/minute * Positive urine pregnancy test or currently breast-feeding * Inability to understand the risks and benefits of the study * The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
References
Publications (0)
Data not yet available