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:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00201942
First received: September 13, 2005
Last updated: October 17, 2007
Last verified: October 2007

September 13, 2005
October 17, 2007
February 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00201942 on ClinicalTrials.gov Archive Site
  • 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.
  • -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
Not Provided
Not Provided
 
PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Procedure: PET scan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
May 2007
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00201942
CTA-Control-092493
Yes
Not Provided
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
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
Ontario Clinical Oncology Group (OCOG)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP