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Completed

NCT Number: NCT02869230

ROLL vs WGLL for Non-palpable Breast Lesions

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ROLL

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

Procedure

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

Primary outcomes

  1. Localization of nonpalpable breast lesion (percentage)

    Time frame: 30 days

Secondary outcomes

  1. presence of malignancy

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia, Columbia

Other Gov

Registry information

Official study title

Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial

Acronym: ROLLvsWGLL

Important dates

Study start
2006
Primary completion
2011
Study completion
2013
First posted
Aug 16, 2016
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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