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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225927
First Posted: September 26, 2005
Last Update Posted: March 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Breast Cancer Foundation
Information provided by:
McMaster University
  Purpose
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).

Condition Intervention
Breast Cancer Invasive Nos Stage 0 Breast Carcinoma Procedure: radioguided seed localization for nonpalpable breast cancers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques [ Time Frame: immediate post-operative pathology results ]

Secondary Outcome Measures:
  • Compare procedure times, complications and volume of tissue excised for both techniques [ Time Frame: intra-operative ]

Enrollment: 333
Study Start Date: June 2004
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225927


Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
McMaster University
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Peter J Lovrics, MD McMaster University
Study Chair: Mary Townsend Administrator for Research Programs, McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Peter J. Lovrics, McMaster University
ClinicalTrials.gov Identifier: NCT00225927     History of Changes
Other Study ID Numbers: 2
First Submitted: September 16, 2005
First Posted: September 26, 2005
Last Update Posted: March 2, 2011
Last Verified: March 2010

Keywords provided by McMaster University:
invasive breast cancer
in situ breast cancer
radioguided seed localization
nonpalpable tumour
needle localization
margin status

Additional relevant MeSH terms:
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type