Back to resultsROLL vs WGLL for Non-palpable Breast Lesions (ROLLvsWGLL)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ROLL
wire-guided lesion localization
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Non palpable breast lesions, radioguided occult lesion localization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Radioguided occult lesion localization
wire-guided lesion localization
Arm Description
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
Outcomes
Primary Outcome Measures
Localization of nonpalpable breast lesion (percentage)
Secondary Outcome Measures
presence of malignancy
Full Information
NCT ID
NCT02869230
First Posted
September 20, 2013
Last Updated
August 11, 2016
Sponsor
Instituto Nacional de Cancerologia, Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02869230
Brief Title
ROLL vs WGLL for Non-palpable Breast Lesions
Acronym
ROLLvsWGLL
Official Title
Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cancerologia, Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Non palpable breast lesions, radioguided occult lesion localization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radioguided occult lesion localization
Arm Type
Other
Arm Description
The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
Arm Title
wire-guided lesion localization
Arm Type
Experimental
Arm Description
wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
Intervention Type
Procedure
Intervention Name(s)
ROLL
Intervention Description
The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
Intervention Type
Procedure
Intervention Name(s)
wire-guided lesion localization
Intervention Description
wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
Primary Outcome Measure Information:
Title
Localization of nonpalpable breast lesion (percentage)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
presence of malignancy
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
faustino bastidas, md
Organizational Affiliation
Instituto Nacional de Cancerología
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
ROLL vs WGLL for Non-palpable Breast Lesions
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