Clinical trial NCT00225927: Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers
Official title: A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Invasive Nos
Stage 0 Breast Carcinoma
Keywords: invasive breast cancer
in situ breast cancer
radioguided seed localization
nonpalpable tumour
needle localization
margin status
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2005-09-26
Enrollment: 333
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive or in situ breast carcinoma
* Nonpalpable breast tumour
* Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques
timeFrame: immediate post-operative pathology results
Secondary outcomes:
measure: Compare procedure times, complications and volume of tissue excised for both techniques
timeFrame: intra-operative
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Peter J Lovrics, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Administrator for Research Programs, McMaster University
name: Mary Townsend
role: STUDY_CHAIR
References:
citation: 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.
citation: Lovrics 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.