Breast Cancer
Conditions
Keywords
FACBC PET/PEM, MR, 11-177
Brief summary
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.
Interventions
PROCEDUREPositron Emission Tomography (PET)
DRUGFluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
PROCEDUREPositron emission mammography (PEM) When available
PROCEDUREMR
Sponsors
GE Healthcare
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess the diagnostic accuracy | 2 years | 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. |
| ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy | 2 years | 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. |
Countries
United States
Outcome results
None listed