MedPath

Choline C-11

Generic Name
Choline C-11
Drug Type
Small Molecule
Chemical Formula
C5H14NO
CAS Number
94793-58-5
Unique Ingredient Identifier
M4AS4XGD4Q

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.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.