Clinical trial · Interventional
Comparison of Two Types of Biopsy in Patients With Breast Lesions
Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy
NCT00006031CI-TRIAL-00008148completedN/AClinicalTrials.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)
RATIONALE: Biopsy is the removal of cells or tissue for examination under a microscope. It is not yet known which type of breast biopsy is more effective for diagnosing breast lesions. PURPOSE: Randomized diagnostic trial to compare the effectiveness of two different types of biopsy in patients who have breast lesions that cannot be felt upon examination.
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 |
|---|---|---|---|
| Low dose radioactive seed followed by surgery and mammogram | Procedure | — | UNRESOLVED |
| Needle localized breast biopsy with specimen x-ray | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- I: Radioactive Seed Localized Breast Biopsy
- description
- Arm I: Patients undergo radiographic placement of a radioactive seed (either iodine I 125 or palladium Pd 103) into the suspicious lesion. Patients then undergo surgery to remove the lesion along with the seed and a small margin of surrounding breast tissue followed 3 months later by a postoperative mammogram.
- interventionNames
- Procedure: Low dose radioactive seed followed by surgery and mammogram
- type
- ACTIVE_COMPARATOR
- label
- Arm II: Needle Localized Breast Biopsy
- description
- Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.
- interventionNames
- Procedure: Needle localized breast biopsy with specimen x-ray
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Suspicious nonpalpable breast lesion requiring breast biopsy for diagnosis OR Nonpalpable breast lesion that is not amenable to core needle biopsy or advanced breast biopsy instrumentation (ABBI) excision Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant PRIOR CONCURRENT THERAPY: Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.