We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00123799
Recruitment Status : Terminated (sufficient enrollment reached)
First Posted : July 26, 2005
Last Update Posted : June 12, 2014
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Positron Emission Tomography Imaging Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00123799

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Principal Investigator: Alexander McEwan, MD AHS Cancer Control Alberta

Additional Information:
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00123799     History of Changes
Other Study ID Numbers: BR-01-0057/DX-FDG-002/17097
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: March 2012

Keywords provided by AHS Cancer Control Alberta:
positron emission tomography
fluorodeoxyglucose F18
sentinel lymph node biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action