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

August 30, 2017 updated by: Memorial Sloan Kettering Cancer Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local staging patients
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: MR
Procedure: Positron Emission Tomography (PET)
Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
Procedure: Positron emission mammography (PEM) When available
Experimental: Neoadjuvant chemotherapy patients
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)
Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
Procedure: Positron emission mammography (PEM) When available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the diagnostic accuracy
Time Frame: 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.
2 years
ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Gary Ulaner, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

August 29, 2017

Study Completion (Actual)

August 29, 2017

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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