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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: PET scan


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PET scan|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Diagnosis, PET, Positronic Emission Tomography, fluorodeoxyglucose