ROLL vs WGLL for Non-palpable Breast Lesions
ROLLvsWGLL
Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial
1 other identifier
interventional
129
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Mar 2006
Longer than P75 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedAugust 16, 2016
September 1, 2013
5.3 years
September 20, 2013
August 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Localization of nonpalpable breast lesion (percentage)
30 days
Secondary Outcomes (1)
presence of malignancy
30 days
Study Arms (2)
Radioguided occult lesion localization
OTHERThe ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
wire-guided lesion localization
EXPERIMENTALwire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
Interventions
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, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
Eligibility Criteria
You may qualify if:
- Female patients older than 18 years
- Lesions suggesting malignancy (BIRADS 4 and 5)
- Solid nodules in postmenopausal women (BIRADS 3 mammograms).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
faustino bastidas, md
Instituto Nacional de Cancerologia de Mexico
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2013
First Posted
August 16, 2016
Study Start
March 1, 2006
Primary Completion
June 1, 2011
Study Completion
May 1, 2013
Last Updated
August 16, 2016
Record last verified: 2013-09