FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 breast-cancer
Started May 2013
Typical duration for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedAugust 31, 2017
August 1, 2017
4.3 years
May 23, 2013
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Local staging patients
EXPERIMENTALBreast 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
EXPERIMENTALBaseline 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- GE Healthcarecollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
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.
PMID: 27856630DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Ulaner, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2013
First Posted
May 29, 2013
Study Start
May 1, 2013
Primary Completion
August 29, 2017
Study Completion
August 29, 2017
Last Updated
August 31, 2017
Record last verified: 2017-08