Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
Conditions
Breast Cancer
Conditions: Keywords
Fluorestradiol (FES), PET/CT scan, Estrogen Receptor, 13-071
Study Type
Interventional
Study Phase
Phase 0
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Fluorestradiol (FES) Type: Drug
Name: PET/CT Imaging Type: Procedure
Overall Status
Recruiting
Summary
These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).

- Patients who are to be treated with clinically approved or experimental regimens where ER has an important role

- ECOG performance status of 0-2.

- Patients must provide written informed consent

Exclusion Criteria:

- Age <18 years

- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)

- Pregnancy or lactation

- Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.

- Serum creatinine > 1.5 times upper limit of normal.
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Gary Ulaner, MD,PhD - 212-639-3776
Start Date
August 2013
Completion Date
August 2018
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page