Overview
Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[18F]fluoro-D-g1ucose, which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection.
Background
Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[18F]fluoro-D-g1ucose, which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection.
Indication
The uptake of 18F-FDG by tissues is a marker for the tissue uptake of glucose, which in turn is closely correlated with certain types of tissue metabolism. Fludeoxyglucose F 18 Injection is indicated in positron emission tomography (PET) imaging 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 diagnoses of cancer.
Associated Conditions
- Cancer
- Coronary Artery Disease (CAD)
- Epileptic seizure
- Left Ventricular Dysfunction
Research Report
Fludeoxyglucose (18F) Report
Name: Fludeoxyglucose (18F) Name (English): Fludeoxyglucose (18F) DrugBank ID: DB09502 Type: Small Molecule CAS Number: 63503-12-8
Fludeoxyglucose (18F), also known as 18F-FDG, is a radioactive tracer used in positron emission tomography (PET) imaging. It is an analog of glucose, where the hydroxyl group at the C-2 position is replaced by a fluorine-18 atom.
Indications: 18F-FDG is used in PET scans to visualize glucose metabolism in the body. Clinically, it is primarily used in:
- Oncology: Detection, staging, and monitoring of various cancers. Cancer cells typically have higher glucose uptake than normal cells.
- Cardiology: Assessment of myocardial viability in patients with coronary artery disease. Viable myocardium exhibits glucose metabolism.
- Neurology: Evaluation of brain glucose metabolism in conditions such as epilepsy, Alzheimer's disease, and brain tumors.
Pharmacodynamics: 18F-FDG is transported into cells by glucose transporters and is phosphorylated by hexokinase to 18F-FDG-6-phosphate. Unlike glucose-6-phosphate, 18F-FDG-6-phosphate cannot be further metabolized and is trapped within the cell. The accumulation of 18F-FDG-6-phosphate reflects the rate of glucose uptake and phosphorylation in tissues.
Pharmacokinetics: Following intravenous administration, 18F-FDG is rapidly distributed throughout the body. It is cleared from most tissues within 24 hours, primarily through urinary excretion.
Adverse Effects: No FDG-specific adverse events have been commonly reported. Reactions are typically related to the injection procedure or potential allergic reactions to other components in the formulation.
Interactions: Medications that affect blood glucose levels, such as corticosteroids, insulin, and antidiabetic agents, can influence 18F-FDG uptake and image interpretation. Colony-stimulating factors can also increase 18F-FDG uptake in the bone marrow.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/17 | Early Phase 1 | ENROLLING_BY_INVITATION | Affiliated Hospital of Jiangnan University | ||
2025/06/17 | Early Phase 1 | ENROLLING_BY_INVITATION | Affiliated Hospital of Jiangnan University | ||
2025/05/30 | Early Phase 1 | Recruiting | |||
2025/05/04 | Phase 2 | Recruiting | Akiva Mintz | ||
2024/12/09 | Not Applicable | ENROLLING_BY_INVITATION | Affiliated Hospital of Jiangnan University | ||
2024/12/06 | N/A | Not yet recruiting | Peking University Cancer Hospital & Institute | ||
2024/12/04 | Not Applicable | Not yet recruiting | Peking University Cancer Hospital & Institute | ||
2024/12/04 | Early Phase 1 | Recruiting | |||
2024/10/17 | N/A | Recruiting | Hua Zhu | ||
2024/09/25 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| University of California, Los Angeles | 76394-3811 | INTRAVENOUS | 40 mCi in 1 mL | 12/1/2022 | |
| The Regents of the University of Michigan | 76326-001 | INTRAVENOUS | 300 mCi in 1 mL | 12/12/2023 | |
| PETNET Solutions, Inc. | 40028-511 | INTRAVENOUS | 200 mCi in 1 mL | 3/9/2023 | |
| MIPS Cyclotron & Radiochemistry Facility | 69587-001 | INTRAVENOUS | 300 mCi in 1 mL | 12/22/2023 | |
| Biomedical Research Foundation of Northwest Louisiana | 24562-003 | INTRAVENOUS | 300 mCi in 1 mL | 6/10/2021 | |
| Kreitchman PET Center | 62072-008 | INTRAVENOUS | 100 mCi in 1 mL | 1/22/2020 | |
| Kettering Medical Center | 29998-001 | INTRAVENOUS | 40 mCi in 1 mL | 10/27/2015 | |
| THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | 13267-234 | INTRAVENOUS | 400 mCi in 1 mL | 7/12/2019 | |
| UIHC-P E T IMAGING CENTER | 24417-001 | INTRAVENOUS | 300 mCi in 1 mL | 10/9/2022 | |
| Hamamatsu/Queen’s PET Imaging Center, LLC | 76376-618 | INTRAVENOUS | 100 mCi in 1 mL | 10/21/2022 |
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. | |||||