Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864083
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer 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 Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Actual Study Start Date : May 2013
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : August 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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: 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
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



Primary Outcome Measures :
  1. 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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864083


Locations
Layout table for location information
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
GE Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Gary Ulaner, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01864083     History of Changes
Other Study ID Numbers: 11-177
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
FACBC PET/PEM
MR
11-177
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs