Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers

NCT ID: NCT00225927

Last Updated: 2011-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Breast Cancer Invasive Nos; Stage 0 Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

radioguided seed localization for nonpalpable breast cancers

radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Peter J Lovrics, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Mary Townsend

Role: STUDY_CHAIR

Administrator for Research Programs, McMaster University

Locations

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22794705 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21533657 (View on PubMed)

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id