ROLL vs WGLL for Non-palpable Breast Lesions (ROLLvsWGLL)

August 11, 2016 updated by: Instituto Nacional de Cancerologia, Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Procedure: ROLL
The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Localization of nonpalpable breast lesion (percentage)
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
presence of malignancy
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia, Columbia

Investigators

  • Study Chair: faustino bastidas, md, Instituto Nacional De Cancerologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C41030610-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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