Breast CancerNCT01901991
Localization of Nonpalpable Breast Lesions
A study testing Radioactive seed localization (RSL) and Wire-guided localization (WGL) in people with Breast Cancer and Carcinoma in Situ, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Carcinoma in Situ
- What is being tested?
- Radioactive seed localization (RSL) and Wire-guided localization (WGL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Feb 2016
- Phase
- Interventional
- 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
- Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary.
- All age groups, minimum 18 years
Who cannot join
- Patients with benign nonpalpable breast lesions.
- Patients who are unable to comprehend the information.
- Patients who are pregnant, breastfeeding or have children < 3 years.
- Patients who have lesions, which requires more than two wires or seeds for localization.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet (Copenhagen University Hospital)
Copenhagen, Østerbro, 2100
About this study
Official title: A Randomized Study of Localization of Nonpalpable Breast Lesions - RSL vs WGL
Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the suspicious lesion completely without removing excess healthy breast tissue. To obtain this accurate lesion localization is essential.
Until today the standard procedure in Denmark has been wire guided localization (WGL). Although the method has been utilized for a number of years it has several disadvantages. Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. It can postpone the additional systemic treatment, offered after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. The wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure.
Read more
The purpose of this study is to test a new method named radioactive seed localization (RSL). The method uses a small titanium seed containing radioactive iodine. It will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. The seed can be placed a few days in advance, which means a more flexible course of treatment. The method seems promising with regards to reoperation rates, but it needs further testing.
Hypothesis:
RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL. Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations.
The study will be performed as a randomised clinical trial, where the two methods will be compared to each other. The trial will be performed at the department of breast surgery at Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.
- Conditions
- Breast Cancer, Carcinoma in Situ
- Being tested
- Radioactive seed localization (RSL), Wire-guided localization (WGL)
- Keywords
- Nonpalpable breast lesions, Breast Cancer and carcinoma in situ, Radioactive seed localization, Wire-guided localization, Randomized study
- Medical subject headings
- Breast Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive seed localization (RSL)Procedure or surgery
Localization of nonpalpable breast lesions with Radioactive seed localization
Wire-guided localization (WGL)Procedure or surgery
Localization of nonpalpable breast lesions with Wire-guided localization
| Study group | Role | What they receive |
|---|---|---|
| Radioactive seed localization (RSL) | Experimental | Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL).
In this arm 205 patients will have RSL performed. The radioactive seed is introduced through a gauge needle using standard ultrasound guidance. Once guided to the nonpalpable breast lesion, the seed is deployed into the breast tissue by advancing a stilette in the needle. The exact location is confirmed by mammography. The nonpalpable lesion is located during the operation with a handheld gamma probe, identical to the one used for the sentinel node procedure. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL. Receives: Procedure: Radioactive seed localization (RSL) |
| Wire-guided localization (WGL) | Active comparator | Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL).
In this arm 205 patients will have WGL performed. Guided by ultrasound or mammography a flexible wire is introduced into the breast by the radiologist just before the operation. The tip of the wire must mark the nonpalpable lesion, and correct localization is verified by mammography. The surgeon uses the wire and mammography as a guide during the operation. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL. Receives: Procedure: Wire-guided localization (WGL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation rate due to positive microscopic margins detected at the final pathological evaluation.
Measured: Re-operation within 3 months after the initial breast conserving surgery.
Secondary outcomes (1)
Amount of excised breast tissue in relation to tumour size.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linnea Langhans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels Kroman, Professor, Study chair, Rigshospitalet (Copenhagen University Hospital), Department of Breast Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901991
- Sponsor's protocol ID
- R72-A4701-13-S9
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be presented in a international peer review article.
Publications
Langhans L, Tvedskov TF, Klausen TL, Jensen MB, Talman ML, Vejborg I, Benian C, Roslind A, Hermansen J, Oturai PS, Bentzon N, Kroman N. Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer: A Randomized, Multicenter, Open-label Trial. Ann Surg. 2017 Jul;266(1):29-35. doi: 10.1097/SLA.0000000000002101.
PubMed 28257326
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Localization of Nonpalpable Breast Lesions - RSL vs WGL
- ClinicalTrials.gov ID
- NCT01901991
- Acronym / sponsor ID
- R72-A4701-13-S9
- Conditions
- Breast Cancer, Carcinoma in Situ
- Keywords
- Nonpalpable breast lesions, Breast Cancer and carcinoma in situ, Radioactive seed localization, Wire-guided localization, Randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Jul 2013 (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.
Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the suspicious lesion completely without removing excess healthy breast tissue. To obtain this accurate lesion localization is essential.
Until today the standard procedure in Denmark has been wire guided localization (WGL). Although the method has been utilized for a number of years it has several disadvantages. Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. It can postpone the additional systemic treatment, offered after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. The wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure.
The purpose of this study is to test a new method named radioactive seed localization (RSL). The method uses a small titanium seed containing radioactive iodine. It will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. The seed can be placed a few days in advance, which means a more flexible course of treatment. The method seems promising with regards to reoperation rates, but it needs further testing.
Hypothesis:
RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL. Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations.
The study will be performed as a randomised clinical trial, where the two methods will be compared to each other. The trial will be performed at the department of breast surgery at Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radioactive seed localization (RSL) | Experimental | Procedure: Radioactive seed localization (RSL)Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL). In this arm 205 patients will have RSL performed. The radioactive seed is introduced through a gauge needle using standard ultrasound guidance. Once guided to the nonpalpable breast lesion, the seed is deployed into the breast tissue by advancing a stilette in the needle. The exact location is confirmed by mammography. The nonpalpable lesion is located during the operation with a handheld gamma probe, identical to the one used for the sentinel node procedure. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL. |
| Wire-guided localization (WGL) | Active comparator | Procedure: Wire-guided localization (WGL)Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL). In this arm 205 patients will have WGL performed. Guided by ultrasound or mammography a flexible wire is introduced into the breast by the radiologist just before the operation. The tip of the wire must mark the nonpalpable lesion, and correct localization is verified by mammography. The surgeon uses the wire and mammography as a guide during the operation. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary.
- All age groups, minimum 18 years
Key exclusion criteria (4 listed)
- Patients with benign nonpalpable breast lesions.
- Patients who are unable to comprehend the information.
- Patients who are pregnant, breastfeeding or have children < 3 years.
- Patients who have lesions, which requires more than two wires or seeds for localization.
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 |
|---|---|---|
| Radioactive seed localization (RSL)Localization of nonpalpable breast lesions with Radioactive seed localization | Procedure or surgery | Radioactive seed localization (RSL) |
| Wire-guided localization (WGL)Localization of nonpalpable breast lesions with Wire-guided localization | Procedure or surgery | Wire-guided localization (WGL) |
Primary outcome
Re-operation rate due to positive microscopic margins detected at the final pathological evaluation.
Time frame: Re-operation within 3 months after the initial breast conserving surgery.
1 secondary outcome
Amount of excised breast tissue in relation to tumour size.
Time frame: 3 months.
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 11 Aug 2017.
- Results publication: PubMed 28257326Langhans L, Tvedskov TF, Klausen TL, Jensen MB, Talman ML, Vejborg I, Benian C, Roslind A, Hermansen J, Oturai PS, Bentzon N, Kroman N. Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer: A Randomized, Multicenter, Open-label Trial. Ann Surg. 2017 Jul;266(1):29-35. doi: 10.1097/SLA.0000000000002101.
- Individual participant dataSharing planned: Yes. Data will be presented in a international peer review article.
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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.
Niels Kroman, Professor study chair
Rigshospitalet (Copenhagen University Hospital), Department of Breast Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive seed localization (RSL) and Wire-guided localization (WGL) in people with Breast Cancer and Carcinoma in Situ, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Re-operation rate due to positive microscopic margins detected at the final pathological evaluation. (time frame: Re-operation within 3 months after the initial breast conserving surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901991, which also lists 1 linked publication.
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 11 Aug 2017.