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

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: 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

• Registration Number: NCT01864083
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-29
• Status Verified: 2017-08
• Primary Completion: 2017-08-29
• Study Completion: 2017-08-29
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy patients	Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)	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.
Neoadjuvant chemotherapy patients	Positron Emission Tomography (PET)	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.
Local staging patients	Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)	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.
Local staging patients	Positron emission mammography (PEM) When available	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.
Neoadjuvant chemotherapy patients	Positron emission mammography (PEM) When available	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.
Local staging patients	Positron Emission Tomography (PET)	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.
Local staging patients	MR	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States