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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00225927
Enrollment
333
Registered
2005-09-26
Start date
2004-06-30
Completion date
2010-06-30
Last updated
2011-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREradioguided 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

Sponsors

Canadian Breast Cancer Foundation
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniquesimmediate post-operative pathology results

Secondary

MeasureTime frame
Compare procedure times, complications and volume of tissue excised for both techniquesintra-operative

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026