Overview
Gadoteridol provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood brain barrier. Gadoteridol can also be used for whole body contrast enhanced MRI including the head, neck, liver, breast, musculoskeletal system and soft tissue pathologies. n MRI, visualization of normal and pathological brain tissue depends in part on variations in the radiofrequency signal intensity that occur with changes in proton density, alteration of the T1, and variation in T2. When placed in a magnetic field, gadoteridol shortens the T1 relaxation time in tissues where it accumulates. Abnormal vascularity or disruption of the blood-brain barrier allows accumulation of gadoteridol in lesions such as neoplasms, abscesses, and subacute infarcts.
Indication
Gadoteridol is indicated for use with magnetic resonance imaging (MRI) in order to visualize lesions with disrupted blood-brain barrier and/or abnormal vascularity in the brain, spine, and associated tissues in adult and pediatric patients, including term neonates. It is also indicated for visualization of lesions in the head and neck in adult patients.
Associated Conditions
- Central nervous system lesion
- Lesions of the Head and Neck
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/23 | Phase 3 | Completed | |||
2023/06/23 | Phase 3 | Completed | |||
2022/05/03 | Early Phase 1 | Completed | |||
2020/10/29 | Phase 1 | Terminated | |||
2020/05/04 | Phase 4 | Recruiting | |||
2018/11/21 | N/A | Completed | |||
2018/01/11 | N/A | Completed | |||
2015/06/25 | Not Applicable | UNKNOWN | |||
2015/02/09 | Not Applicable | Completed | |||
2012/06/07 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BRACCO DIAGNOSTICS INC | 0270-1111 | INTRAVENOUS | 279.3 mg in 1 mL | 1/24/2024 |
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 |
|---|---|---|---|---|---|
| Gadoteridol Injection | 国药准字H20223329 | 化学药品 | 注射剂 | 5/25/2022 | |
| Gadoteridol Injection | 国药准字H20244916 | 化学药品 | 注射剂 | 9/19/2024 | |
| Gadoteridol Injection | 国药准字HJ20140111 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字HJ20140400 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字HJ20140402 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字HJ20140401 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字HJ20140113 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字HJ20140112 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gadoteridol Injection | 国药准字H20223328 | 化学药品 | 注射剂 | 5/25/2022 | |
| Gadoteridol Injection | 国药准字H20243918 | 化学药品 | 注射剂 | 6/4/2024 |
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 |
|---|---|---|---|---|---|
| PROHANCE gadoteridol 5586mg/20mL injection vial | 72672 | Medicine | A | 9/6/2000 | |
| PROHANCE gadoteridol 4189.5mg/15mL injection vial | 72671 | Medicine | A | 9/1/2000 | |
| PROHANCE gadoteridol 2793mg/10mL injection vial | 263733 | Medicine | A | 4/26/2016 | |
| PROHANCE gadoteridol 2793mg/10mL injection syringe | 72674 | Medicine | A | 9/6/2000 | |
| PROHANCE gadoteridol 4189.5mg/15mL injection syringe | 72675 | Medicine | A | 9/1/2000 |
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