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Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection

This study has been terminated.
(sufficient enrollment reached)
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00123799
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

Breast cancer affects many women. One of the places to which it can spread is the lymph glands under the arm. The type of treatment offered to patients often will depend on whether those lymph glands have cancer in them or not. For this reason, a standard recommendation is that women with breast cancer have these lymph glands removed with surgery. This cancer causes side effects including numbness, pain, decreased ability to move the arm and arm swelling. A new type of surgery which looks only at the first gland that a cancer drains to (sentinel node biopsy) may help to avoid having to remove the glands under the arm. Also, a new way of imaging the glands under the arm called Positron Emission Tomography (PET) scanning may also give a better idea of the chance that these glands have cancer in them. This study is determining whether PET scans before surgery and sentinel node biopsy can decrease the need for a complete axillary dissection.


Condition Intervention Phase
Breast Neoplasms
 Procedure: Positron Emission Tomography Imaging
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase II Study of Fluorodeoxyglucose (FluGlucoScan) in Patients With Breast Cancer: Correlation With Histologic Findings of Sentinel Node Biopsies and Axillary Dissection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • to determine whether preoperative PET imaging combined with sentinel node biopsy can accurately identify axillary node status
  • to assess the size limitations of PET scanning in metastatic lymph nodes

Secondary Outcome Measures:
  • to determine the incidence of unsuspected distant metastases in patients with breast cancer
  • to determine the value of a delayed scan time of approximately three hours after the injection of 18F-FDG

Enrollment: 199
Study Start Date: June 2004
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female. If female of child bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test.
  • Biopsy proven breast carcinoma (core biopsy or fine needle aspiration, although core biopsies are preferred.)
  • Tumour size T1-3, N0 clinically
  • All patients will have pre-operative mammography +/- ultrasound of the breast
  • Age equal to or greater than 18 years
  • Able and willing to follow instructions and comply with the protocol
  • Provide written informed consent prior to participation in this study

Exclusion Criteria:

  • Nursing or pregnant females
  • Previous malignancy or diagnosis less than 10 (ten) years ago. Skin cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
  • Excisional biopsy of the tumour has been performed
  • Age less than 18 years
  • Patient has diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123799

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Alexander McEwan, MD Alberta Health Services
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00123799     History of Changes
Other Study ID Numbers: BR-01-0057/DX-FDG-002/17097
Study First Received: July 22, 2005
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
positron emission tomography
fluorodeoxyglucose F18
sentinel lymph node biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Deoxyglucose
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013