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ROLL vs WGLL for Non-palpable Breast Lesions

Phase 2
Completed
Conditions
Breast Cancer
Registration Number
NCT02869230
Lead Sponsor
Instituto Nacional de Cancerologia, Columbia
Brief Summary

Here were present a controlled clinical trial comparing wire-guided lesion localization (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in Bogotá,Colombia.

Detailed Description

The aim of this study was to compare the radioguided occult lesion localization (ROLL) technique with the wire-guided lesion localization (WGLL) technique to assess the optimal localization and excision of nonpalpable breast lesions in patients at a unique reference medical center.

A controlled clinical trial was designed to compare the WGLL and ROLL techniques in women presenting with breast lesions diagnosed by mammography or ultrasound at the Instituto Nacional de Cancerología in Bogotá, Colombia from March 2006 to June 2011.

This study evaluate 129 patients; 64 (49.6%) patients were treated using ROLL and 65 (51.4%) using WGLL.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
129
Inclusion Criteria
  • Female patients older than 18 years
  • Lesions suggesting malignancy (BIRADS 4 and 5)
  • Solid nodules in postmenopausal women (BIRADS 3 mammograms).
Exclusion Criteria
  • Pregnant or nursing
  • Patients with suspected multifocal or multicentric disease (suspicious microcalcifications scattered over a wide area on mammography)
  • Patients with retro-areola lesions (less than 2 cm away from the nipple)
  • Lesions that had previously undergone surgery or excisional biopsies in the compromised breast

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Localization of nonpalpable breast lesion (percentage)30 days
Secondary Outcome Measures
NameTimeMethod
presence of malignancy30 days

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