Breast Cancer Invasive NosNCT00225927
Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers
A study testing radioguided seed localization for nonpalpable breast cancers in people with Breast Cancer Invasive Nos and Stage 0 Breast Carcinoma, run by McMaster University at 3 sites in Canada.
Trial summary
The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive Nos, Stage 0 Breast Carcinoma
- What is being tested?
- radioguided seed localization for nonpalpable breast cancers
- Type of treatment
- Surgery or procedure
- How many people
- 333 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2004to Jun 2010
- 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
- Histologically confirmed invasive or in situ breast carcinoma
- Nonpalpable breast tumour
- Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation
Who cannot join
- Histological confirmation more than 3 months from enrollment
- Pregnancy or lactation
- Contraindication to BCS or patient requests mastectomy
- Age less than 18 years
- Male patient
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers
The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).
Read the detailed description
Most breast cancers are removed by partial mastectomy/lumpectomy. The most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. Complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. If the margin is positive, or the cancer recurs, more surgery or mastectomy is required. Approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (needle localization) has a higher chance of having cancer cells at the margin. This is a study about a surgical technique. The objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. The main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. An improved technique would benefit thousands of women every year.
- Being tested
- radioguided seed localization for nonpalpable breast cancers
- Keywords
- invasive breast cancer, in situ breast cancer, radioguided seed localization, nonpalpable tumour, needle localization, margin status
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioguided seed localization for nonpalpable breast cancersProcedure or surgery
radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques
Measured: immediate post-operative pathology results
Secondary outcomes (1)
Compare procedure times, complications and volume of tissue excised for both techniques
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Invasive NosStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Investigators
- Peter J Lovrics, MD, Principal investigator, McMaster UniversityMary Townsend, Study chair, Administrator for Research Programs, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225927
- Sponsor's protocol ID
- 2
- Status last verified
- Mar 2010
- First submitted
- 16 Sep 2005
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Reedijk M, Hodgson N, Gohla G, Boylan C, Goldsmith CH, Foster G, Cornacchi SD, McCready D, Lovrics PJ. A prospective study of tumor and technical factors associated with positive margins in breast-conservation therapy for nonpalpable malignancy. Am J Surg. 2012 Sep;204(3):263-8. doi: 10.1016/j.amjsurg.2012.03.007. Epub 2012 Jul 12.
PubMed 22794705Lovrics PJ, Goldsmith CH, Hodgson N, McCready D, Gohla G, Boylan C, Cornacchi S, Reedijk M. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol. 2011 Nov;18(12):3407-14. doi: 10.1245/s10434-011-1699-y. Epub 2011 Apr 30.
PubMed 21533657
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers
- ClinicalTrials.gov ID
- NCT00225927
- Acronym / sponsor ID
- 2
- Keywords
- invasive breast cancer, in situ breast cancer, radioguided seed localization, nonpalpable tumour, needle localization, margin status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Jun 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Sep 2005 (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.
The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).
Detailed description
Most breast cancers are removed by partial mastectomy/lumpectomy. The most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. Complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. If the margin is positive, or the cancer recurs, more surgery or mastectomy is required. Approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (needle localization) has a higher chance of having cancer cells at the margin. This is a study about a surgical technique. The objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. The main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. An improved technique would benefit thousands of women every year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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)
- Histologically confirmed invasive or in situ breast carcinoma
- Nonpalpable breast tumour
- Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation
Key exclusion criteria (5 listed)
- Histological confirmation more than 3 months from enrollment
- Pregnancy or lactation
- Contraindication to BCS or patient requests mastectomy
- Age less than 18 years
- Male patient
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 |
|---|---|---|
| radioguided seed localization for nonpalpable breast cancersradio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery | Procedure or surgery | – |
Primary outcome
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques
Time frame: immediate post-operative pathology results
1 secondary outcome
Compare procedure times, complications and volume of tissue excised for both techniques
Time frame: intra-operative
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 2 Mar 2011.
- Derived from this study: PubMed 22794705Reedijk M, Hodgson N, Gohla G, Boylan C, Goldsmith CH, Foster G, Cornacchi SD, McCready D, Lovrics PJ. A prospective study of tumor and technical factors associated with positive margins in breast-conservation therapy for nonpalpable malignancy. Am J Surg. 2012 Sep;204(3):263-8. doi: 10.1016/j.amjsurg.2012.03.007. Epub 2012 Jul 12.
- Derived from this study: PubMed 21533657Lovrics PJ, Goldsmith CH, Hodgson N, McCready D, Gohla G, Boylan C, Cornacchi S, Reedijk M. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol. 2011 Nov;18(12):3407-14. doi: 10.1245/s10434-011-1699-y. Epub 2011 Apr 30.
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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.
Peter J Lovrics, MD principal investigator
McMaster University
Mary Townsend study chair
Administrator for Research Programs, McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radioguided seed localization for nonpalpable breast cancers in people with Breast Cancer Invasive Nos and Stage 0 Breast Carcinoma, run by McMaster University at 3 sites in Canada.
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 5 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 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques (time frame: immediate post-operative pathology results). 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 NCT00225927, which also lists 2 linked publications.
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 2 Mar 2011.