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

NCT00225927 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 3

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare procedure times, complications and volume of tissue excised for both techniques

  intra-operative

Interventions

radioguided seed localization for nonpalpable breast cancers PROCEDURE

radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive or in situ breast carcinoma
• Nonpalpable breast tumour
• Candidate for breast conserving surgery (BCS) based on clinical and radiologic evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (3)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Reedijk M, Hodgson N, Gohla G, Boylan C, Goldsmith CH, Foster G, Cornacchi SD, McCready D, Lovrics PJ. A prospective study of tumor and technical factors associated with positive margins in breast-conservation therapy for nonpalpable malignancy. Am J Surg. 2012 Sep;204(3):263-8. doi: 10.1016/j.amjsurg.2012.03.007. Epub 2012 Jul 12.

  PMID: 22794705 DERIVED

• Lovrics PJ, Goldsmith CH, Hodgson N, McCready D, Gohla G, Boylan C, Cornacchi S, Reedijk M. A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas. Ann Surg Oncol. 2011 Nov;18(12):3407-14. doi: 10.1245/s10434-011-1699-y. Epub 2011 Apr 30.

  PMID: 21533657 DERIVED

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter J Lovrics, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Mary Townsend

  Administrator for Research Programs, McMaster University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 26, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 2, 2011

Record last verified: 2010-03

Locations

CA (3)