Recently, relevant research results of a multi-center phase I/II clinical trial of differentiated thyroid cancer, which was initiated by Department of Nuclear Medicine of Peking Union Medical College Hospital and participated by Department of Nuclear Medicine of the First Affiliated Hospital of Xi 'an Jiaotong University (XJTU), were published as an article entitled “Novel recombinant human thyroid-stimulating hormone in aiding postoperative assessment of patients with differentiated thyroid cancer-phase I/II study” in European Journal of Nuclear Medicine and Molecular Imaging. It is the most influential top-notched academic journal in the field of nuclear medicine worldwide, which is classified as Top Area I by JCR and Chinese Academy of Sciences, with an impact factor of 10.057 in 2021.
This clinical study was designed to evaluate the tolerance, safety and efficacy of recombinant human thyroid-stimulating hormone (rhTSH, ZGrhTSH) in postoperative radioactive iodine (RAI) therapy and follow-up of patients with differentiated thyroid cancer (DTC). The findings demonstrate that compared with traditional follow-up and thyroid hormone withdrawal, ZGrhTSH has the identical potential in increasing TSH level, facilitating RAI uptake and serum thyroglobulin (Tg) stimulation in DTC patients. Besides, it can significantly improve patients' quality of life and yield high tolerance, providing a better alternative for postoperative treatment and evaluation for DTC patients.
On November 29, 2019, National Health Commission and National Medical Products Administration jointly issued the "Regulations for the Administration of Drug Clinical Trial Institutions". Drug clinical trial institutions shall be subject to record filing management in lieu of accreditation. On April 7, 2020, Department of Nuclear Medicine of our hospital successfully completed the record filing inspection for drug clinical trial institutions, and became the first-batch new specialties. Professor Yang Aimin and Professor Gao Rui from Department of Nuclear Medicine successfully passed the researcher certification. Department of Nuclear Medicine closely follows the development blueprint of our hospital and actively participates in national multi-center clinical research. At present, the department has undertaken 6 domestic multi-center drug clinical research projects (2 phase II and 3 phase III studies), and has completed 3 projects. The patient enrollment rate ranks among the leading positions in China.
Article link:https://link.springer.com/article/10.1007/s00259-022-05865-y
