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

NCT00123799 | Terminated Phase 2

• 1 other identifier: BR-01-0057/DX-FDG-002/17097
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

positron emission tomography; fluorodeoxyglucose F18; sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

Positron Emission Tomography Imaging PROCEDURE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexander McEwan, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: June 1, 2004
• Study Completion: April 1, 2007
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CA (1)