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Clinical Trial · NCT03507088
Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer
Overview
Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer
Sponsor
Fudan University
Phase
N/A
Contacts
Zhiming Shao, M.D (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03507088Drug / Compound
Fluoroestradiol
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Estrogen Receptor
Ligand Class: Small Molecules
Eligibility
Inclusion
- No previous fulvestrant treatment
- ECOG 0-2
- Life expectancy \> 6 months
- Able to comply with the protocol
- ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed.
- Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence.
Exclusion
- Evidence of central nervous system metastases
- \> 3 lines of endocrine therapy for metastatic disease
- Isolated liver metastasis (high FES uptake by normal liver)
- Presence of life-threatening visceral metastases
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