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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201942
First Posted: September 20, 2005
Last Update Posted: October 18, 2007
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.
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Ontario Clinical Oncology Group (OCOG)
  Purpose

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.


Condition Intervention Phase
Breast Cancer Procedure: PET scan Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 336
Study Start Date: February 2005
Study Completion Date: May 2007
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.
  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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): NCT00201942


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

ClinicalTrials.gov Identifier: NCT00201942     History of Changes
Other Study ID Numbers: CTA-Control-092493
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 18, 2007
Last Verified: October 2007

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Breast Cancer
Diagnosis
PET
Positronic Emission Tomography
fluorodeoxyglucose

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases