Clinical trial · Interventional
Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
NCT01852032CI-TRIAL-00032525completedN/AResults postedClinicalTrials.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 purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.
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 |
|---|---|---|---|
| Breast CT Scanning | Radiation | — | UNRESOLVED |
| Tomosynthesis Breast Scanning | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer Patients
- description
- Tomosynthesis Breast Scanning is done and breast CT Scanning is done.
- interventionNames
- Radiation: Tomosynthesis Breast Scanning
- Radiation: Breast CT Scanning
Primary outcomes (5)
- measure
- Beta of CT Coronal View
- timeFrame
- Day 1
- description
- frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
- measure
- Beta of CT Sagittal View
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * 35 years of age or older * While male patients will not be explicitly excluded, it is expected that all patients in this study will be women * Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5 * Scheduled for ultrasound or stereotactic core biopsy * Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration. * Ability to understand risks, procedures, and benefits involved Exclusion Criteria: * Recent breast biopsy * History of breast augmentation implant * Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding * History of moderate or severe adverse reaction to iodinated contrast injection * Recent serum creatinine ≥ 1.5 mg/dL * History of Diabetes Mellitus * Currently taking Glucophage or Glucovance (Metformin) * History of chronic asthma * History of allergy to iodine * Multiple food and/or drug allergy * Renal disease * History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold
References
Publications (0)
Data not yet available
No reference posted for this study.