Find a Trial Find Expert Physicians 
News Trial Stats
Clinical TrialsFacts & Fears Who pays for it, placebos, being a guinea pig, and what taking part really means.Basics ofTheranostics A fundamental way of finding and treating your cancer, all in one.Basics ofRadiation What is radiation, and how can it benefit you? InterpretingYour Scans What CT, MRI and PET can and can’t tell you about cancer.What to Expect as aTheranostic Patient Scans, treatment day, and the precautions once you are home.Basics ofDosimetry How much radiation each organ and tumor actually absorbs.TheranosticDictionary Plain-language meanings for the vocabulary on your paperwork.
News Trial StatsDark mode
Contact XCancer®
Mon–Thu 8am–4:30pm CT · Fri 8am–3pm CT
Clinical Trial · NCT04883814
18F-fluoroestradiol (FES) PET/CT for Breast Cancer
Overview
The standard of care imaging of breast cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. 18F-fluoroestradiol (FES) is a novel PET tracer designed to detect estrogen receptors, which are often expressed in breast cancers. FES PET/CT may provide improved evaluation of metastases in patients with ER-positive breast cancer.
Sponsor
Hoag Memorial Hospital Presbyterian
Phase
Phase 2
Contacts
Gary Ulaner, MD, PhD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04883814Drug / 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
- For cohort 2: Suspected recurrent disease and plan for CT/bone scan systemic staging
- For cohort 1: Stage 2B-3C locally advanced disease and plan for CT/bone scan systemic staging or
- ECOG performance status 0 to 2
- Either:
- Histologically confirmed ER-positve breast cancer. Any pathology from a primary or metastatic breast cancer site demonstrating ER-positivity will be allowed.
Exclusion
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Selective ER Modulators (SERMs) such as tamoxifen and Selective ER Degraders (SERDs) such as fulvestrant may reduce detection of ER-positive lesions by FES. Thus, exclusion criteria specify that patients must be withdrawn from Selective ER Modifiers for at least 8 weeks and withdrawn from Selective ER Degraders for for least 24 weeks prior to performance of the FES PET/CT.
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
- Pregnant or breastfeeding
Share your feedback
Help us improve your experience