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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer Invasive Nos, Stage 0 Breast Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the number of positive margins following excision of the nonpalpable breast tumours for the two different surgical techniques

Outcome Time Frame:

immediate post-operative pathology results

Safety Issue:

No

Principal Investigator

Peter J Lovrics, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University

Authority:

Canada: Canadian Nuclear Safety Commission

Study ID:

2

NCT ID:

NCT00225927

Start Date:

June 2004

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer Invasive Nos
  • Stage 0 Breast Carcinoma
  • invasive breast cancer
  • in situ breast cancer
  • radioguided seed localization
  • nonpalpable tumour
  • needle localization
  • margin status
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ

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