Prospective validation of 18F-Fluoroethylcholine as a tracer in PET/MRI for the evaluation of breast lesions and prediction of lymph node status

Purpose To assess 18F-Fluoroethylcholine (18F-FEC) as a PET/MRI tracer in the evaluation of breast lesions, breast cancer aggressiveness, and prediction of lymph node status. Materials and methods This prospective, monocentric study was approved by the ethics committee and patients gave written, informed consent. This clinical trial was registered in the EudraCT database (Number 2017-003089-29). Women who presented with suspicious breast lesions were included. Histopathology was used as reference standard. Simultaneous 18F-FEC PET/MRI of the breast was performed in a prone position with a dedicated breast coil. MRI was performed using a standard protocol before and after contrast agent administration. A simultaneous read by nuclear medicine physicians and radiologists collected the imaging data of MRI-detected lesions, including the maximum standardized 18F-FEC-uptake value of breast lesions (SUV maxT ) and axillary lymph nodes (SUV maxLN ). Differences in SUV max were evaluated with the Mann–Whitney U test. To calculate diagnostic performance, the area under the receiver operating characteristics curve (ROC) was used. Results There were 101 patients (mean age 52.3 years, standard deviation 12.0) with 117 breast lesions included (30 benign, 7 ductal carcinomas in situ, 80 invasive carcinomas). 18F-FEC was well tolerated by all patients. The ROC to distinguish benign from malignant breast lesions was 0.846. SUV maxT was higher if lesions were malignant ( p < 0.001), had a higher proliferation rate ( p = 0.011), and were HER2-positive ( p = 0.041). SUV maxLN was higher in metastatic lymph nodes, with an ROC of 0.761 for SUV maxT and of 0.793 for SUV maxLN. Conclusion Simultaneous 18F-FEC PET/MRI is safe and has the potential to be used for the evaluation of breast cancer aggressiveness, and prediction of lymph node status.