Choline c-11

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 radiolabeled analog of choline, a precursor molecule essential for the biosynthesis of cell membrane phospholipids. Choline is involved in synthesis of the structural components of cell membranes, as well as modulation of trans-membrane signaling. Increased phospholipid synthesis (i.e., increased uptake of choline) has been associated with cell proliferation and the transformation process that occurs in tumor cells.

Aseptically withdraw Choline C 11 Injection from its container and administer 370 – 740 MBq (10 – 20 mCi) as a bolus intravenous injection. The radioactivity dose (370 – 740 MBq, 10 – 20 mCi) is chosen based on patient body dimensions and the characteristics of the image acquisition system. Initiate imaging immediately after administration of Choline C 11 Injection and acquire static emission images 0 – 15 minutes from the time of injection. The effective radiation absorbed dose from 740 MBq (20 mCi) dose of Choline C 11 Injection is approximately 3.22 mSv (0.32 rem) in an adult. Image interpretation: Refer to full prescribing information.

None. None.

Imaging errors have been reported, blood PSA levels < 2 ng/mL have been associated with poor imaging performance. Allergic reactions: have emergency resuscitation equipment and personnel readily available. 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.

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.

Colchicine and androgen-deprivation therapeutic drugs have been reported to interfere with choline-based PET imaging. 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 relationship but published reports suggest 11 C-choline PET imaging may be productive in patients with “hormone resistant” recurrent prostate cancer even if the patients are receiving anti-androgen therapy. Imaging may prove unproductive or misleading due to failed or insufficient 11 C-choline uptake in patients with hormone-responsive cancer if the patients are receiving androgen-deprivation therapy. Colchicine and androgen-deprivation therapeutic drugs may interfere with 11 C-choline PET/CT imaging performance.

Store Choline C 11 Injection at 25°C (77°F), excursions permitted to 15 – 30°C (59 – 86°F).