NCT00201942

Brief Summary

The overall goal of this study is to determine how FDG-PET can be incorporated into the assessment of the axilla in the staging and treatment of women with early stage breast cancer. A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the presence or absence of axillary lymph node metastases in newly diagnosed breast cancer patients with no clinical evidence of spread of disease beyond the breast.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 18, 2007

Status Verified

October 1, 2007

First QC Date

September 13, 2005

Last Update Submit

October 17, 2007

Conditions

Breast Cancer

Keywords

Breast CancerDiagnosisPETPositronic Emission Tomographyfluorodeoxyglucose

Outcome Measures

Primary Outcomes (1)

  • The primary outcomes are the sensitivity and specificity of FDG-PET in axillary node assessments using axillary node assessment [Sentinel Node Biopsy(SNB) with or without Axillary Node Dissection (AND)] as the reference standard.

Secondary Outcomes (3)

  • Patients with positive FDG-PET in non-axillary nodal areas;

  • Patients with positive FDG-PET in other non-nodal areas;

  • Patients with positive FDG-PET in the residual breast tissue.

Interventions

PET scanPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of invasive breast cancer,
  • Resectable primary cancer.

You may not qualify if:

  • The diagnosis of invasive breast cancer was made more than 3 months prior to registration,
  • Patient and/or surgeon are not willing to proceed with a SNB or AND after the PET scan is completed,
  • Patient and/or surgeon are not willing to proceed with a level I and II AND if the SNB is positive, if the PET scan shows increased uptake in the ipsilateral axilla, or if the surgeon is still gaining experience in the performance of SNB,
  • SNB or AND has already been done,
  • Chemotherapy has been given or will be given prior to PET scan or SNB or AND,
  • Significant serious concurrent medical problems (e.g., uncontrolled diabetes),
  • Patient is pregnant or lactating,
  • Patient is unable to lie supine and with both arms above their heads for PET scan,
  • Known hypersensitivity to FDG,
  • Clinical evidence of regional nodal metastases (fixed, matted axillary nodes),
  • Clinical evidence of distant metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

St. Joseph's

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1Y 4K7, Canada

Location

North York

Toronto, Ontario, M2J 1V1, Canada

Location

Sunnybrook Regional Cancer Centre and Women's College

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsDisease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Kathleen Pritchard, MD

    Sunnybrook Regional Cancer Centre

    STUDY CHAIR

  • Claire Holloway, MD

    Sunnybrook Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

  • David McCready, MD

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

  • Jim Julian, M.Math.

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Mark N Levine, MD

    Ontario Clinical Oncology Group (OCOG)

    PRINCIPAL INVESTIGATOR

  • Wendy Shelley, MD

    Kingston Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Karen Gulenchyn, MD, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Frances O'Malley, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

February 1, 2005

Study Completion

May 1, 2007

Last Updated

October 18, 2007

Record last verified: 2007-10

Locations

CA(10)