Back to resultsFACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Tomography (PET)
Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
Positron emission mammography (PEM) When available
MR
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring FACBC PET/PEM, MR, 11-177
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Local staging patients
Neoadjuvant chemotherapy patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01864083
First Posted
May 23, 2013
Last Updated
August 30, 2017
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01864083
Brief Title
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Official Title
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
August 29, 2017 (Actual)
Study Completion Date
August 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
GE Healthcare
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
FACBC PET/PEM, MR, 11-177
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local staging patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Neoadjuvant chemotherapy patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Intervention Type
Drug
Intervention Name(s)
Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
Intervention Type
Procedure
Intervention Name(s)
Positron emission mammography (PEM) When available
Intervention Type
Procedure
Intervention Name(s)
MR
Primary Outcome Measure Information:
Title
assess the diagnostic accuracy
Description
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
Title
ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ulaner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27856630
Citation
Ulaner GA, Goldman DA, Corben A, Lyashchenko SK, Gonen M, Lewis JS, Dickler M. Prospective Clinical Trial of 18F-Fluciclovine PET/CT for Determining the Response to Neoadjuvant Therapy in Invasive Ductal and Invasive Lobular Breast Cancers. J Nucl Med. 2017 Jul;58(7):1037-1042. doi: 10.2967/jnumed.116.183335. Epub 2016 Nov 17.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
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