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

Breast Cancer Invasive Nos Clinical Trial

Official title:

A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225927
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: February 28, 2011
• Start date: June 2004
• Est. completion date: June 2010

Study information

• Verified date: March 2010
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Nuclear Safety CommissionCanada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer Invasive Nos
• Breast Neoplasms
• Carcinoma in Situ
• Stage 0 Breast Carcinoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques		immediate post-operative pathology results	No
Secondary	Compare procedure times, complications and volume of tissue excised for both techniques		intra-operative	No