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

Early Phase 1CompletedNCT01864083

Memorial Sloan Kettering Cancer Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Positron Emission Tomography (PET)PROCEDURE

Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)DRUG

Positron emission mammography (PEM) When availablePROCEDURE

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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