ROLL vs WGLL for Non-palpable Breast Lesions

Breast Cancer Clinical Trial

— ROLLvsWGLL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869230
• Other study ID #: C41030610-019
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2013
• Last updated: August 11, 2016
• Start date: March 2006
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Instituto Nacional de Cancerologia, Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• ROLL
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia, Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization of nonpalpable breast lesion (percentage)		30 days	No
Secondary	presence of malignancy		30 days	No