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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer Invasive Nos, Stage 0 Breast Carcinoma

Intervention / Treatment
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* Procedure: radioguided seed localization for nonpalpable breast cancers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques |  | immediate post-operative pathology results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare procedure times, complications and volume of tissue excised for both techniques |  | intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive breast cancer, in situ breast cancer, radioguided seed localization, nonpalpable tumour, needle localization, margin status