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

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00225927
First received: September 16, 2005
Last updated: February 28, 2011
Last verified: March 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare procedure times, complications and volume of tissue excised for both techniques [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225927

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
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

No publications provided by McMaster University

Additional 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
Study First Received: September 16, 2005
Last Updated: February 28, 2011
Health Authority: Canada: Canadian Nuclear Safety Commission
Canada: Ministry of Health & Long Term Care, Ontario

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
Carcinoma in Situ
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014