Clinical trial · Interventional
Diagnostic Study of Early Breast Cancer Using Ultrasound
Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer
NCT01391039CI-TRIAL-00019972terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.
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 |
|---|---|---|---|
| Ductal Carcinoma In-situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perflutren lipid microsphere | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast perfusion and elastography arm
- description
- Intravenous injection of microbubble contrast agent and elastography
- interventionNames
- Drug: Perflutren lipid microsphere
Primary outcomes (1)
- measure
- Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.
- timeFrame
- The participant will be followed up till the results of the biopsy, an expected average of 3 months.
Secondary outcomes (1)
- measure
- Measurement of transient shear wave elastography .
- timeFrame
- The participant will be followed up till the results of the biopsy, an expected average of 3 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study. * At least 18 years of age Exclusion Criteria: * Pregnant or possibly pregnant or breast feeding * Unable to provide informed consent * Drug or multiple allergies * Known cardiac shunts * Known cardiac or chronic pulmonary disease * Hypersensitivity to perflutren
References
Publications (0)
Data not yet available
No reference posted for this study.