Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
129 participants
INTERVENTIONAL
2006-03-31
2013-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Lesions suggesting malignancy (BIRADS 4 and 5)
* Solid nodules in postmenopausal women (BIRADS 3 mammograms).
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Instituto Nacional de Cancerologia, Columbia
OTHER_GOV
Responsible Party
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Principal Investigators
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faustino bastidas, md
Role: STUDY_CHAIR
Instituto Nacional de Cancerologia de Mexico
Other Identifiers
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C41030610-019
Identifier Type: -
Identifier Source: org_study_id
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