What is the generic name?

CHOLINE C 11

What is the Trade Name for CHOLINE C 11?

Choline C 11

What are the Indications for CHOLINE C 11?

• 1 INDICATIONS AND USAGE 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 Use: 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 Use: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer (1).

References: https://open.fda.gov/