---
title: Comparison of Two Types of Biopsy in Patients With Breast Lesions
nct_id: NCT00006031
overall_status: COMPLETED
phase: NA
sponsor: H. Lee Moffitt Cancer Center and Research Institute
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00006031.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00006031"
ct_last_update_post_date: 2012-09-26
last_seen_at: "2026-05-12T07:10:26.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of Two Types of Biopsy in Patients With Breast Lesions

**Official Title:** Randomized Prospective Trial Comparing Radioactive Seed Localized Breast Biopsy to Needle Localized Breast Biopsy

**NCT ID:** [NCT00006031](https://clinicaltrials.gov/study/NCT00006031)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 117
- **Lead Sponsor:** H. Lee Moffitt Cancer Center and Research Institute
- **Collaborators:** National Cancer Institute (NCI)
- **Conditions:** Breast Cancer
- **Start Date:** 1999-11
- **Completion Date:** 2006-07
- **CT.gov Last Update:** 2012-09-26

## Brief Summary

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.

## Detailed Description

OBJECTIVES: I. Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time and tissue loss in patients with nonpalpable breast lesions. II. Compare the cost effectiveness of these diagnostic methods in these patients. III. Demonstrate that radioactive seed localization allows for elimination of specimen x-ray in these patients. IV. Demonstrate that radioactive seeds may be placed safely for 1-7 days prior to surgical removal in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two diagnostic arms. 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. Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **I: Radioactive Seed Localized Breast Biopsy** (ACTIVE_COMPARATOR) — 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.
- **Arm II: Needle Localized Breast Biopsy** (ACTIVE_COMPARATOR) — Arm II: Patients undergo a needle localized breast biopsy with a specimen x-ray.

## Interventions

- **Needle localized breast biopsy with specimen x-ray** (PROCEDURE)
- **Low dose radioactive seed followed by surgery and mammogram** (PROCEDURE) — either iodine I 125 or palladium Pd 103

## Primary Outcomes

- **Tissue Loss Rates for Each Arm** _(time frame: 18 months)_ — Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on tissue loss in patients with nonpalpable breast lesions.
- **Operative Time Rates in Each Group** _(time frame: 18 months)_ — Compare the effect of low dose radioactive seed localized breast biopsy versus needle localized breast biopsy on operative time in patients with nonpalpable breast lesions.

## Secondary Outcomes

- **Number of Participants with Adverse Events for Each Group** _(time frame: 18 months)_

## Locations (1)

- H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.h. lee moffitt cancer center and research institute|tampa|florida|united states` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00006031*  
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