Overview
Fluoroestradiol F-18 is an imaging agent used with positron emission tomography (PET) to detect estrogen receptor-positive breast cancer lesions. The ability to image ER-positive tumors in vivo is advantageous in that, while helping to visualize tumor progression/regression, it may also be used to assess for heterogeneity in ER expression across metastases (i.e. to identify sites that no longer express ER) without the need for multiple biopsies. Fluoroestradiol F-18 was first granted FDA approval in May 2020, and will be developed by PETNET Solutions, Inc. and Zionexa USA under the brand name Cerianna. It is expected to be available in late 2020/early 2021.
Indication
Fluoroestradiol F-18 is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Associated Conditions
- Metastatic Estrogen Receptor Positive Breast Cancer
- Recurrent Estrogen Receptor Positive Breast Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/15 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2023/06/23 | Phase 2 | Recruiting | |||
2022/12/21 | Early Phase 1 | Recruiting | |||
2020/12/31 | Phase 2 | Active, not recruiting | |||
2020/05/11 | Phase 2 | Completed | |||
2020/04/15 | Phase 1 | Withdrawn | Annie (Annie) T. Packard | ||
2018/10/12 | Phase 2 | Completed | |||
2015/03/26 | Phase 2 | Active, not recruiting | |||
2015/03/02 | Early Phase 1 | Terminated | |||
2014/05/29 | Not Applicable | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| GE Healthcare Inc. | 72874-001 | INTRAVENOUS | 100 mCi in 1 mL | 8/1/2023 |
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. | |||||
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