유니콜린연질캡슐(콜린알포세레이트)

Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1 ).

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Imaging errors have been reported; blood PSA levels < 2 ng/mL have been associated with poor imaging performance ( 5.1 ). Allergic reactions: have emergency resuscitation equipment and personnel readily available ( 5.2 ). Radiation risk: Choline C 11 Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect the patient and health care worker ( 5.3 ). 5.1 Imaging Errors Imaging errors have been reported with 11 C-choline PET and PET/CT imaging. A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent cancer. 11C-choline uptake is not specific for prostate cancer and may occur with other types of cancer (such as lung carcinoma and brain tumors). Clinical correlation, including histopathological evaluation of the suspected recurrence site, is essential to proper use of the PET imaging information. Blood PSA levels < 2 ng/mL have been associated with poor performance of 11 C-choline PET imaging (higher numbers of false positive and false negative results) [see Clinical Studies (14) ] . Tissue inflammation as well as prostatic hyperplasia have been associated with false positive 11 C-choline PET images. Concomitant colchicine or androgen-deprivation therapeutic drugs (such as luteinizing hormone-releasing analogs and anti-androgen drugs) may interfere with 11 C-choline PET imaging. One published report of 18 F-methylcholine PET imaging indicated …

8.1 Pregnancy Pregnancy Category C. There are no adequate and well controlled studies with Choline C 11 Injection in pregnant women and the fetal radiation dose from a 11 C-choline PET imaging study is unknown. It is not known whether Choline C 11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with 11 C-choline. All radiopharmaceuticals, including Choline C 11 Injection, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose. Assess pregnancy status before administering Choline C …