Clinical trial · Observational
Role of 3D Tomography in Breast Cancer
NCT01090687CI-TRIAL-00011526completedClinicalTrials.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 pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.
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 (CT scan) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group I Microcalcifications
- description
- After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan.
- interventionNames
- Radiation: computed tomography (CT scan)
- label
- Group II Soft tissue findings
- description
- After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan.
- interventionNames
- Device: computed tomography (CT scan)
Primary outcomes (1)
- measure
- Correlation between mammography and breast CT on lesion detection
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below. * Able to provide informed consent. Exclusion Criteria: * Males * Women less than 40 years old * Pregnant women * Lactating women * Woman who have had bilateral mastectomies * Women 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 * Women who are unable to tolerate study constraints, frail or unable to cooperate * Women with large breasts that cannot be accommodated within the field of view of the CT system * Women 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 Hodgkin's disease * Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Women 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.