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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Fluorestradiol (FES)
* Procedure: PET/CT Imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (FES) PET/CT for Imaging<br>FES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction. If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan. | Drug: Fluorestradiol (FES)<br> <br> Procedure: PET/CT Imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FES PET/CT scanning | The objective of this study is only to allow FES PET/CT scanning of patients at MSKCC. This protocol is an umbrella protocol to allow FES PET/CT scanning to be used in other companion protocols. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorestradiol (FES), PET/CT scan, Estrogen Receptor, 13-071