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[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer an Exploratory Study

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[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer an Exploratory Study Journal of Nuclear Medicine, published on April 7, 2016 as doi:10.2967/jnumed.115.171389 Anti-3-[18F] FACBC (Fluciclovine) PET-CT of Breast Cancer: An Exploratory Study Funmilayo I. Tade1, Michael A. Cohen1, Toncred M. Styblo2, Oluwaseun A. Odewole1, Anna I. Holbrook1, Mary S. Newell1, Bital Savir-Baruch3, Xiaoxian Li4, Mark M. Goodman1, Jonathon A Nye1, David M. Schuster1. Author affiliations: 1. Radiology and Imaging Sciences, Emory University, Atlanta, GA, USA 2. Surgery, Emory University, Atlanta, GA, USA 3. Radiology, Loyola University Medical Center, Maywood, Illinois, USA 4. Pathology and Laboratory Medicine, Emory University, Atlanta, GA, USA Corresponding Author: David M. Schuster, MD; Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-4859, Fax: 404-712-4860, email: [email protected] First Author: Funmilayo Tade, MD, MPH; Research Fellow, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University Hospital, 1364 Clifton Road, Atlanta, GA 30322. Telephone: 404-712-1348, Fax: 404-712-4860, email: [email protected] Word Count: 4,946 Grant Sponsor: Glenn Family Breast Center Grant; Winship Cancer Institute, Emory University. FLUCICLOVINE PET-CT IN BREAST CANCER The purpose of this study is to explore the uptake of the synthetic amino acid analog positron emission tomography (PET) radiotracer anti-3-[18F] FACBC (fluciclovine) in breast lesions with correlation to histologic and immunohistochemical characteristics. Methods Twelve women with breast lesions underwent 45 minute dynamic PET-CT of the thorax after intravenous administration of 366.3 ±14.8 (337.44 - 394.05) MBq of fluciclovine. Uptake in the primary lesions at 4 representative time points (5, 17, 29, 41 min) after injection were correlated with histologic, imaging, and clinical findings. The significance of differences in maximum standard uptake value (SUVmax) and tumor to background ratios between malignant and benign tissue were calculated. Correlation of activity to histologic and immunohistochemical cancer subtypes were made including Ki-67 intensity and Nottingham Grade (NG). Results There were 17 breast lesions (4 benign, 13 malignant) including 7/13 invasive ductal, 5/13 invasive lobular, and 1/13 metaplastic carcinomas. There was a significant difference in mean SUVmax ± standard deviation (SD) of malignant (6.2±3.2, 6.0±3.2, 5.7±2.8, and 5.6±3.0) vs benign (1.3±0.6, 1.2±0.5, 1.2±0.6 and 1.1±0.5) lesions at 5, 17, 29 and 41mins respectively (all p≤0.0001). Tumor to background (aorta, normal breast and marrow) ratios were also significantly higher in malignant compared to benign breast lesions (all P≤0.02). Highest fluciclovine activity seems to be present in triple negative and NG3 subtypes. Across time points, quantitative Ki-67 had weak positive correlation with SUVmax [R1=0.48(P=0.03), R2=0.44(P=0.03), R3= 0.46(P=0.03), R4 =0.43(0.06)]. In 7 patients, fluciclovine PET visualized locoregional and distant spread including that of lobular cancer, though identification of hepatic metastases was limited by physiologic background activity. Conclusion The uptake characteristics of fluciclovine are reflective of the histologic and immunohistochemical characteristics in suspect breast lesions with greater activity in malignant versus benign etiology. The data from this exploratory study may be useful to design future studies utilizing fluciclovine PET for breast tumor imaging as well as for detection of locoregional and distant spread. 2 Keywords: FACBC, Fluciclovine, PET, breast cancer 3 INTRODUCTION Breast cancer is the most common cancer and the second leading cause of cancer related deaths in women (1). Histologic and molecular characteristics of breast cancer have significant effects on therapeutic decisions as well as disease-free and overall survival (2). Mammography, ultrasound and Magnetic Resonance Imaging (MRI) form the backbone of breast imaging (3-6). (18F) fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has also assumed an important role in whole body staging, detection of recurrent disease and monitoring therapy response (7). Molecular breast imaging with 18F-FDG positron emission mammography (PEM) and technetium (99mTc) sestamibi are also being explored (3,8,9). These have limitations including differentiation of malignancy from post-therapy effects and challenges with certain histologic subtypes such as lobular cancer, which accounts for 10% of invasive breast cancers. Thus, molecular imaging targeting receptors or other aspects of the metabolome are under investigation (8,9). Since amino acid metabolism is upregulated in breast cancer, molecular imaging utilizing natural or synthetic amino acid radiotracers is a potentially attractive approach (9,10). Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) is a synthetic amino acid analog transported via system L (LAT1) and ASCT (ASCT2) amino acid transporters and has shown promise in the imaging of prostate and other cancers (11). Liang reported fluciclovine uptake in breast carcinoma cell lines which correlated with malignant potential as well as in orthotopic MDA-MB-231 breast carcinoma xenografts (12). In this study, we aimed to explore uptake of fluciclovine in suspicious breast lesions, report associations between uptake and histologic as well as immunohistochemical characteristics of breast carcinoma and to describe activity within locoregional or remote tumor spread. 4 MATERIALS AND METHODS Patient selection The institutional review board at Emory University approved this study which is HIPAA compliant and all subjects signed a written informed consent. 12 female patients ≥18 years with breast lesion(s) naïve to therapy and about to undergo biopsy or at least 1 week post-biopsy were recruited and underwent fluciclovine PET-CT between September 2012 and January 2015 (NCT01659645). Fluciclovine PET-CT imaging Preparation of fluciclovine under Investigational New Drug Application 72,437 was completed via the GE FastLab Cassette System or via automated synthesis (13). All subjects fasted for at least 4 hours to stabilize plasma amino acid levels (14). A CT of the thorax (80-120 mA; 120 kVp) was done then, 366.3 ±14.8 (337.44 - 394.05) MBq of fluciclovine was injected intravenously and a 45-minute dynamic list mode PET acquisition at one table position encompassing the primary breast lesion(s) was completed in a Discovery 690 PET-CT scanner (GE, Milwaukee, WI). Data was reconstructed into 4-minute time frames and transferred to a MIMVista workstation (MIM Software; Cleveland, OH) for analysis. 4 patients also had clinical 18F-FDG-PET performed on the same scanner after intravenous injection of 439.84±37MBq 18F-FDG and uptake time of approximately 60 minutes. Blood glucose ranged from 89 -104 mg/dl in these patients. Fluciclovine and 18F-FDG scans were at an average (±SD; range) interval of 12 (±8; 1-21) days. Safety Evaluation Vitals signs were monitored during and immediately after the fluciclovine scan. Complete metabolic profile, complete blood count and urinalysis just prior to and approximately 1week after the fluciclovine PET were obtained and no attributable adverse events were noted. Dosimetry and phase 1 safety data have already been reported (15-17). 5 Image analysis A board certified nuclear radiologist unblinded to all correlative imaging and clinical information using the 3 dimensional PET-Edge tool and a custom workflow (MIM Software; Cleveland, OH) drew target and background regions of interest. After drawing the region of interest, the values of the maximum voxel (SUVmax), average voxel (SUVmean) and the average of all voxels within a fixed spherical ROI of 1cm3 centered on the most metabolically active part of the lesion (SUVpeak) were recorded at representative time points of 5-8mins, 17-20mins, 29-32mins and 41-44mins (referenced as 5, 17, 29, and 41 min in this paper). SUV mean of background structures (blood pool at aortic arch, “normal” breast tissue and marrow at T5 vertebrae) were also measured using at least a 1cc spherical region of interest best conforming to the background structure. For normal breast tissue, regions either contralateral or most distant from suspect lesions were chosen. Images were scrutinized for marker clips, and if present, were correlated to surgical reports for associations between imaging and histologic sampling. In ill-defined or multifocal breast lesions or in a nodal conglomerate, the most representative region was measured. Histologic analysis Histological examination of biopsy specimens was carried out by a board certified breast pathologist to evaluate the Nottingham Grade (NG1, NG2, and NG3). Immunohistochemical analysis was performed for estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor (HER2) and Ki-67, using DAKO, HERCEPTEST and MIB-1 kits respectively. ER and PR expression was positive if ≥ 1% of the tumor nuclei were stained (18). HER2 was negative if staining was 0 or 1+; equivocal if 2+ and positive if 3+ per American Society of Clinical Oncology /College of American Pathologists guidelines. We analyzed HER2 equivocal cases by FISH study to determine HER2 gene amplification. Ki-67 staining was scored as the number of positively stained nuclei as a percentage of the total tumor cells and reported in three categories: low, ≤10%; intermediate, >10% - <14%; and high, ≥14%. Statistical methods Two-tailed t-test was used to compare the means of SUVmax in malignant to that of benign breast tumors and SUVmax of benign breast tumors to that of normal breast tissue across time points. Analysis of variance was used to compare the means of SUVmax of malignant lesions based on Nottingham grades, molecular subtypes and 6 Ki-67. Pearson’s correlation coefficient was used to determine the correlation between SUVmax and Ki-67 intensity (%) in malignant breast tumors. Correlation coefficient (R) was interpreted as very strong: 0.9-1.0; strong: 0.7- <0.9; moderate: 0.5-<0.7; weak: 0.3- <0.5; none: <0.3.
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