FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

Study Overview
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Brief Summary
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This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.

Official Title
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FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Positron Emission Tomography (PET)
* Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
* Procedure: Positron emission mammography (PEM) When available
* Procedure: MR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC No prior therapy for IDC or ILC Clinical need for local disease staging with breast MR (Group A only) Clinical need for neoadjuvant chemotherapy (Group B only) Patients must provide written informed consent Exclusion Criteria: Age <21 years Men Pregnancy or lactation Patients who have already started treatment for the current malignancy Patients who cannot undergo PET scanning (i.e. because of weight limits) Patients who are known to have contraindication for MRI (e.g. metal implants) Patients may only participate in group #1 or group #2, but not both

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local staging patients<br>Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard. | Procedure: Positron Emission Tomography (PET)<br> <br> Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)<br> <br> Procedure: Positron emission mammography (PEM) When available<br> <br> Procedure: MR<br> <br> |
| Experimental: Neoadjuvant chemotherapy patients<br>Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management. | Procedure: Positron Emission Tomography (PET)<br> <br> Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)<br> <br> Procedure: Positron emission mammography (PEM) When available<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the diagnostic accuracy | Accuracy of standardized uptake values will be analyzed by receiver operating characteristic (ROC) curves. ROC curves will be constructed separately for FACBC PET, FACBC PEM and MR. The area under the curve will be used as a summary measure and compared using the standard nonparametric test [20]. We will also consider dichotomizing the uptake and present accuracy using sensitivity, specificity and predictive values. Dichotomized values will be compared using the McNemar test. | 2 years | 
| ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy | Patients with locally advanced IDC or ILC, requiring neoadjuvant therapy prior to definitive surgery, will undergo FACBC PET and PEM both before chemotherapy and after. Following definitive breast surgery, pathologic specimens will be analyzed to determine if FACBC imaging can predict pathologic treatment response. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FACBC PET/PEM, MR, 11-177