Overview
Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of pat ients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging.
Indication
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, imag es w ere produced with PET/CT coregistration.
Associated Conditions
- Prostate Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Perdido Key Health and Wellness Inc | 70104-806 | INTRAMUSCULAR | 1 mg in 1 mL | 11/23/2015 | |
Mayo Clinic | 52670-556 | INTRAVENOUS | 33.1 mCi in 1 mL | 1/10/2024 | |
Decatur Memorial Hospital | 73410-004 | INTRAVENOUS | 4 mCi in 1 mL | 11/6/2019 | |
The University of Texas MD Anderson Cancer Center | 60215-111 | INTRAVENOUS | 100 mCi in 1 mL | 12/19/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.