ROLL vs WGLL for Non-palpable Breast Lesions

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02869230

Acronym

ROLLvsWGLL

Enrollment

129

Registered

2016-08-16

Start date

2006-03-31

Completion date

2013-05-31

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Non palpable breast lesions, radioguided occult lesion localization

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.

Interventions

PROCEDUREROLL

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

PROCEDUREwire-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Localization of nonpalpable breast lesion (percentage)	30 days

Secondary

Measure	Time frame
presence of malignancy	30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026