PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)

October 17, 2007 updated by: Ontario Clinical Oncology Group (OCOG)

A Prospective Study to Determine the Role of 2-[18F]Fluoro-2-Deoxy-D-Glucose (FDG)Positron Emission Tomography (PET)in the Assessment of Regional Nodal Spread of Disease in Breast Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will have histologic confirmation of invasive breast cancer and will have a FDG-PET scan prior to axillary node assessment. All patients will have a sentinel node biopsy if any sentinel nodes can be located. Patients with a positive sentinel node will have an axillary node dissection. The results of the PET will be compared to the reference standard of histologic examination of all excised (sentinel and non-sentinel) axillary lymph nodes which will be referred to as axillary node assessment. Sensitivity, specificity, positive and negative predictive values for PET-FDG will be determined.

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1Y 4K7
        • Ottawa Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's
      • Toronto, Ontario, Canada, M2J 1V1
        • North York
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Regional Cancer Centre and Women's College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

Investigators

  • Study Chair: Kathleen Pritchard, MD, Sunnybrook Regional Cancer Centre
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 18, 2007

Last Update Submitted That Met QC Criteria

October 17, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTA-Control-092493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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