Breast Cancer Clinical Trial

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

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.

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Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

54

Study ID:

NCT01916122

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

54

Study ID:

NCT01916122

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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