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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864083
• Other study ID #: 11-177
• Status: Completed
• Phase: Early Phase 1
• First received: May 23, 2013
• Last updated: August 30, 2017
• Start date: May 2013
• Est. completion date: August 29, 2017

Study information

• Verified date: August 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 29, 2017
• Est. primary completion date: August 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Positron Emission Tomography (PET)

Drug:
• Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Procedure:
• Positron emission mammography (PEM) When available

• MR

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center