Choline C 11

Choline C 11

Choline C 11 Recall

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

History

There is currently no drug history available for this drug.

Other Information

11.1 Chemical Characteristics

Choline C 11 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with PET imaging. The active ingredient, 11C-choline, has the molecular formula of C411CH14 NOCl with a molecular weight of 138.63 g and has the following chemical structure:


choline-c-11-01

Choline C 11 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each milliliter contains 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution. The pH of the solution is between 4.5 and 7.5.

11.2 Physical Characteristics

Carbon 11 is a cyclotron-produced radionuclide that decays to Boron 11 by positron emission and has a physical half life of 20.4 minutes (Table 2).

Table 2: Principal Radiation Emission Data for 11C
*Produced by positron annihilation
Radiation/Emission % Per Disintegration Energy
Positron (β+)
 
99.76 960.2 keV (Max.)
Gamma (±)*
 
199.5 511 keV

The specific gamma ray constant (point source air kerma coefficient) for 11C-choline is 5.8 R/mCi-hr at 1 cm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1,000.

Table 3: Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield Thickness (Pb) mm Coefficient of Attenuation
4 0.5
8 0.25
13 0.1
26 0.01
39 0.001
52 0.0001

Table 4 lists fractions remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

Table 4: Physical Decay Chart for 11C
*Calibration time
Minutes Fraction Remaining
0* 1.000
5 0.844
10 0.712
15 0.600
20 0.507
25 0.427
30 0.360

Choline C 11 Manufacturers


  • Mayo Clinic
    Choline C 11 Injection [Mayo Clinic]
  • Precision Nuclear Llc
    Choline C 11 Injection [Precision Nuclear Llc]
  • Mayo Clinic
    Choline C 11 (Choline C-11) Injection [Mayo Clinic]

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