Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/5/2018
Start Date:August 2013
End Date:August 2020
Contact:Gary Ulaner, MD, PhD
Phone:212-639-3776

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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.


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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Gary Ulaner, MD, PhD
Phone: 212-639-3776
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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