Breast CancerPhase 2ROLLvsWGLLNCT02869230
ROLL vs WGLL for Non-palpable Breast Lesions
A Phase 2 study testing ROLL and wire-guided lesion localization in people with Breast Cancer, run by Instituto Nacional de Cancerologia, Columbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ROLL and wire-guided lesion localization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients older than 18 years
- Lesions suggesting malignancy (BIRADS 4 and 5)
- Solid nodules in postmenopausal women (BIRADS 3 mammograms).
Who cannot join
- 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
About this study
Official title: Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- ROLL, wire-guided lesion localization
- Keywords
- Breast cancer, Non palpable breast lesions, radioguided occult lesion localization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROLLProcedure or surgery
The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
wire-guided lesion localizationProcedure or surgery
wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
| Study group | Role | What they receive |
|---|---|---|
| Radioguided occult lesion localization | Other | The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion Receives: Procedure: ROLL |
| wire-guided lesion localization | Experimental | wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes Receives: Procedure: wire-guided lesion localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization of nonpalpable breast lesion (percentage)
Measured: 30 days
Secondary outcomes (1)
presence of malignancy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMar 2006
- Primary completionJun 2011
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- faustino bastidas, md, Study chair, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869230
- Sponsor's protocol ID
- C41030610-019
- Acronym
- ROLLvsWGLL
- Status last verified
- Sep 2013
- First submitted
- 20 Sep 2013
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02869230
- Acronym / sponsor ID
- ROLLvsWGLL / C41030610-019
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Non palpable breast lesions, radioguided occult lesion localization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Study start
- Mar 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radioguided occult lesion localization | Other | Procedure: ROLLThe ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion |
| wire-guided lesion localization | Experimental | Procedure: wire-guided lesion localizationwire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients older than 18 years
- Lesions suggesting malignancy (BIRADS 4 and 5)
- Solid nodules in postmenopausal women (BIRADS 3 mammograms).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROLLThe ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion | Procedure or surgery | Radioguided occult lesion localization |
| wire-guided lesion localizationwire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes | Procedure or surgery | wire-guided lesion localization |
Primary outcome
Localization of nonpalpable breast lesion (percentage)
Time frame: 30 days
1 secondary outcome
presence of malignancy
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
faustino bastidas, md study chair
Instituto Nacional de Cancerologia de Mexico
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ROLL and wire-guided lesion localization in people with Breast Cancer, run by Instituto Nacional de Cancerologia, Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localization of nonpalpable breast lesion (percentage) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.