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

Instituto Nacional de Cancerologia, Columbia

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: wire-guided lesion localization; Procedure: ROLL

Study type: Interventional

Funder types: Other

Identifiers

NCT02869230

C41030610-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Radioguided occult lesion localization

Other group

Description:

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

Treatment:

Procedure: ROLL

wire-guided lesion localization

Experimental group

Description:

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

Treatment:

Procedure: wire-guided lesion localization