ROLL vs WGLL for Non-palpable Breast Lesions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: ROLL
* Procedure: wire-guided lesion localization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radioguided occult lesion localization<br>The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion | Procedure: ROLL<br>* The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion<br>|
| Experimental: wire-guided lesion localization<br>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<br>* wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization of nonpalpable breast lesion (percentage) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of malignancy |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Non palpable breast lesions, radioguided occult lesion localization