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Flotufolastat (18F)
Flotufolastat (18F) is a fluorine-18 labeled folate analog that binds to folate receptors on cancer cells for positron emission tomography (PET) imaging.
Flotufolastat (18F) is a fluorine-18 labeled folate analog that binds to folate receptors on cancer cells for positron emission tomography (PET) imaging. Used for PET imaging of folate receptor-positive tumors in oncology patients.
At a glance
| Generic name | Flotufolastat (18F) |
|---|---|
| Sponsor | Blue Earth Diagnostics |
| Drug class | Folate receptor-targeted PET imaging agent |
| Target | Folate receptor alpha (FR-α) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
This radiopharmaceutical is designed to target folate receptor-positive tumors by mimicking folate and binding to folate receptors that are overexpressed on many cancer cell types. The fluorine-18 radiolabel enables PET imaging to visualize and localize folate receptor-expressing lesions in patients with suspected or known malignancies. This allows for improved detection, staging, and monitoring of folate receptor-positive cancers.
Approved indications
- PET imaging of folate receptor-positive tumors in oncology patients
Common side effects
Key clinical trials
- Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (PHASE2)
- Comparing a New PSMA Imaging Agent to MRI for Detecting Prostate Cancer, BEACON Trial (EARLY_PHASE1)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance (PHASE2)
- Androgen-responsive POSLUMA-guided Intra-prostatic Boost (PHASE2)
- Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC (PHASE1, PHASE2)
- Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer (PHASE1)
- POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |