ROLL vs WGLL for Non-palpable Breast Lesions

NCT ID: NCT02869230

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Radioguided occult lesion localization

The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion

Group Type OTHER

ROLL

Intervention Type PROCEDURE

The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion

wire-guided lesion localization

wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes

Group Type EXPERIMENTAL

wire-guided lesion localization

Intervention Type PROCEDURE

wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes

Interventions

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ROLL

The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion

Intervention Type PROCEDURE

wire-guided lesion localization

wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cancerologia, Columbia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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faustino bastidas, md

Role: STUDY_CHAIR

Instituto Nacional de Cancerologia de Mexico

Other Identifiers

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C41030610-019

Identifier Type: -

Identifier Source: org_study_id

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