Fludeoxyglucose F18

Fludeoxyglucose F18

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Uses

Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

1.1 Oncology

For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

1.2 Cardiology

For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

1.3 Neurology

For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

1.1 Oncology

For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

1.2 Cardiology

For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

1.3 Neurology

For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

History

There is currently no drug history available for this drug.

Other Information

11.1 Chemical Characteristics

Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[18F]fluoro-D-glucose has the molecular formula of C6H1118FO5 with a molecular weight of 181.26, and has the following chemical structure:

fdg structure

Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20-400 mCi) of 2-deoxy-2-[18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.

11.2 Physical Characteristics

Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2).

Table 2. Principal Radiation Emission Data for Fluorine F 18
Radiation/Emission% Per DisintegrationMean Energy
Positron(β+)96.73249.8 keV
Gamma(±)*193.46511.0 keV

*Produced by positron annihilation

From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)

The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.

Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield thickness (Pb) mmCoefficient of attenuation
0
0.00
4
0.50
8
0.25
13
0.10
26
0.01
39
0.001
52
0.0001

For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.


Table 4. Physical Decay Chart for Fluorine F 18
MinutesFraction Remaining
0*
1.000
15
0.909
30
0.826
60
0.683
110
0.500
220
0.250

*calibration time

11.1 Chemical Characteristics

Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[18F]fluoro-D-glucose has the molecular formula of C6H1118FO5 with a molecular weight of 181.26, and has the following chemical structure:

fdg structure

Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20-400 mCi) of 2-deoxy-2-[18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.

11.2 Physical Characteristics

Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2).

Table 2. Principal Radiation Emission Data for Fluorine F 18
Radiation/Emission% Per DisintegrationMean Energy
Positron(β+)96.73249.8 keV
Gamma(±)*193.46511.0 keV

*Produced by positron annihilation

From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)

The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.

Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield thickness (Pb) mmCoefficient of attenuation
0
0.00
4
0.50
8
0.25
13
0.10
26
0.01
39
0.001
52
0.0001

For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.


Table 4. Physical Decay Chart for Fluorine F 18
MinutesFraction Remaining
0*
1.000
15
0.909
30
0.826
60
0.683
110
0.500
220
0.250

*calibration time

Fludeoxyglucose F18 Manufacturers


  • The Feinstein Institute For Medical Research
    Fludeoxyglucose F18 Injection [The Feinstein Institute For Medical Research]
  • The Methodist Hospital Research Institute
    Fludeoxyglucose F18 Injection, Solution [The Methodist Hospital Research Institute]
  • Biomedical Research Foundation Of Northwest Louisiana
    Fludeoxyglucose F18 (Fludeoxyglucose F-18) Injection, Solution [Biomedical Research Foundation Of Northwest Louisiana]
  • Biomedical Research Foundation Of Northwest Louisiana
    Fludeoxyglucose F18 (Fludeoxyglucose F-18) Injection, Solution [Biomedical Research Foundation Of Northwest Louisiana]
  • The Feinstein Institute For Medical Research
    Fludeoxyglucose F18 Injection [The Feinstein Institute For Medical Research]
  • Cyclotron Partners Lp Dba Cyclotope
    Fludeoxyglucose F18 Injection [Cyclotron Partners Lp Dba Cyclotope]
  • Wisconsin Medical Cyclotron Llc
    Fludeoxyglucose F18 (Fludeoxyglucose F-18) Injection, Solution [Wisconsin Medical Cyclotron Llc]
  • Essential Isotopes Llc
    Fludeoxyglucose F18 Injection [Essential Isotopes Llc]
  • The University Of Texas Md Anderson Cancer Center
    Fludeoxyglucose F18 Injection [The University Of Texas Md Anderson Cancer Center]
  • Ucsf Radiopharmaceutical Facility
    Fludeoxyglucose F18 (Fludeoxyglucose F18) Injection [Ucsf Radiopharmaceutical Facility]

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