Choline C 11
Generic: CHOLINE C-11
Basic Information
Manufacturer
Mayo Clinic
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8e046642-5038-4094-b1bb-a1915558fb1c
Indications & Usage
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 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 ).
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 ).
Adverse Reactions
6 ADVERSE REACTIONS 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
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