CHOLINE C-11

Distribution: 11 C-choline distributes mainly to the pancreas, kidneys, liver, spleen and colon [see Dosage and Administration (2.4) ]. Based upon the relatively low urinary excretion of radioactivity, renal distribution is predominantly to the organ itself, rather than via formation of urine. Metabolism: Following intravenous administration, 11 C-choline undergoes metabolism resulting in the detection of 11 C-betaine as the major metabolite in blood. In a study of patients with prostate cancer...

A systematic review of published reports identified four studies that contained data sufficient to compare 11 C-choline PET imaging to histopathology (truth standard) among patients with suspected prostate cancer recurrence and non-informative conventional imaging (for most patients, CT or MRI). In general, the suspected recurrence criteria consisted of at least two sequential PSA levels of > 0.2 ng/mL for men who had undergone prostatectomy and PSA levels of ≥ 2 ng/mL above the post-therapy nadir for men who had undergone radiotherapy. The studies were predominantly single clinical site exper...

Exclusive of an uncommon, mild injection site reaction, no adverse reactions to 11 C-choline have been reported. Exclusive of an uncommon, mild injection site reaction, no other adverse reactions have been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Division of Nuclear Medicine, Department of Radiology, Mayo Clinic at 507-284-2511 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

None. None ( 4 ).

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. ...

7 DRUG INTERACTIONS Colchicine and androgen-deprivation therapeutic drugs have been reported to interfere with choline-based PET imaging [see Warnings and Precautions (5.1) ]. The impact of androgen-deprivation therapeutic drugs upon 11 C-choline PET imaging may depend upon the hormonal responsiveness of a patient’s recurrent prostate cancer. Clinical studies have not established this relationshi...